{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-19", "results": { "skip": 0, "limit": 1, "total": 21 } }, "results": [ { "proprietary_name": [ "5052-3 - ALP STRAPS W/FOAM BOOTS (PR)", "5840-726R - ASSY, IMAGING TABLE TOP, 500 LBS, REFURB", "5847-06 - PELVIC SCREW ADAPTER ASSEMBLY", "5875-04 - MLPD EXTENSION POST, 2.2\"", "5927R - RADIOLUCENT IMAGING TOP (500#),REFURB", "6850-3000 - COVER, 6850 ProFx TABLE", "6850-487 - Hana/ProFx Traction Boot XLarge (pr)", "6875-370R - SPAR, LEG, RIGHT,RADIOLUCENT,REFURBISHED", "6875-602 - FEMUR LIFT EMERGENCY HANDLE", "6879-10-2 - ASSY, SPAR MOUNT, SSXT, EU RAIL", "6977-898 - COVER, AXIS MODULAR SYSTEM", "6988-449 - RETRACTER ADAPTER, RADIOLUCENT", "6988-880R - RETRACTOR ADAPTOR REFURB", "7887-050R - LEVO ARM, REFURBISHED", "7887-400R - Levo Package 4: Premium, Refurbished", "5300-1 - PUBIC LATERAL POSITIONER", "5338-100 - LATERAL SUPPORT PAD ASSEMBLY", "5371R - Arthroscopic Leg Holder, Refurbished", "5847-3000 - COVER, 5847-07 PELVIC CART", "5848-87 - HAND CRANK, STRAIGHT", "5855-838R - WELL LEG SUPPORT ASSEMBLY, REFURBISHED", "5943R - MTS SPINAL SURGERY TOP, REFURB", "6300-93R - HANA/PROFX 90 DEG PIN AND WIRE HOLDER, REFURBISHED", "6850-500 - LATERAL PERINEAL POST, CURVED", "6850-97 - ATTACHMENT MOUNTING BRACKET", "6895-1347 - ADANTE EXTENDED SADDLE POST", "6895-93 - Adante Knee Pad Support Mount, Left", "6988-623 - ProAxis Head-End Supine Top", "7803-390R - VECTOR, TRACTION, REFURBISHED", "7887-803R - QUICKCONNECT RADIOLUCENT MAYFIELD,REFURB", "FE00388 - TRACTION BOOT LINERS, XLARGE", "5321-43 - WHEELED STORAGE CART", "5399 - EUROPEAN COMBO CLAMP", "5840-370 - STS H-Frame", "5848-223 - PRK PERINEAL POST", "5855-193 - Trios/OTS TRACTION EXTENSION LONG", "5855-930 - Trios/OTS Tibia Well Leg Support", "6300-92 - Hana/ProFx Articulating Bracket", "6807-7 - HAND PENDANT, 6977", "6844-169R - INSITE SUPINE TOP WITH PAD, REFURBISHED", "6850-2101R - SPAR ASSEMBLY, LEFT, REFURBISHED", "6850-910 - LATERAL TRACTION DEVICE", "6870R - HANA SSXT- AA THA UNIT REFURB", "6875-500 - Hana Equipment Cart", "6977-4006RF - KIT, FRU, CNTL BOX W/MNTS 120V REFURB", "7803-574 - Trios Spinal Surgery Frame", "974 - Inflatable Bladder (8x10in)", "5356 - PIVOTING ARM BOARD W/TEMPUR 2IN", "5806 - 5' RADIOLUCENT IMAGING TOP (350 LBS)", "5855-136 - TIBIA COUNTER TRACTION ASSY", "5855-440 - TRACTION FOOT PLATE", "5855-865R - TRACTION BOOT W/PLATE,X-LARGE,L&R,REFURB", "5863 - ORTHOPEDIC TRACTION ARC CART", "6807-1 - HAND PENDANT, ADVANCED CONTROL BASE", "6850-169 - SIDE RAIL SOCKET ADAPTER ASSEMBLY", "6870-41 - HAND CRANK ASSEMBLY", "6875-208 - ASSEMBLY BASE KNEEFLEXATION", "6956-3 - HIP PAD, TEMPUR PEDIC COMFORT, LARGE", "6977-502 - RAIL ASSEMBLY, LEFT", "7803-479 - UPGRADE KIT, COUPLER, TRIOS", "7855 - Trios Orthopedic Trauma Top", "5275-5 - LEG ASSEMBLY, HAND SURGERY TABLE", "5362-6 - PIVOTING ARM BOARD ASSY W/OUT PAD", "5847-157 - HAND CRANK, 45 DEGREE", "5855-753 - Trios/OTS WELL LEG SUPPORT SWING ARM", "5875-06 - MLPD EXTENSION POST, 6\"", "5939-L - COMBO HIP/THIGH PAD, LEFT", "6850-490 - BILATERAL MOUNTING BRACKET", "6875-3900 - HANA LEG SPAR LIFT ASSIST, LEFT", "6895-1110 - Adante Femoral Hook Bracket", "6977-959 - Side Rail Adapter 6in", "6988-526 - ProAxis/Insite Arm Board Bracket", "6988-887R - ASSY, RAIL SHEATH, RIGHT, REFURBISHED", "7803-279R - ASSY, ADJUSTABLE TABLE MOUNT,REFURBISHED", "7887-060R - LEVO Z-TOWER, SIDE CRANK, REFURBISHED", "7887-801R - QUICKCONNECT ALUMINUM SKULL CLAMP,REFURB", "5840-601 - DUAL CHEST PAD, LEFT", "5855-345 - Traction Unit", "5875-01 - MAIN PLATFORM ASSEMBLY", "6836-10R - 10mm WELL HIP FIXATION FRAME (6850), REFURB", "6850-27R - PROFX TRACTION BOOT ADAPTOR ASSY, REFURBISHED", "6875-20 - TABLE COVER, 6875 HANA", "6875-326i - REPLACEMENT HANA BASE, ASSY, 220V", "6875-600R - ASSEMBLY, FEMUR LIFT RH, REFURBISHED", "6876-10 - ASSY, SPAR MOUNT, SSXT, MAQUET 1140", "6977-4162R - DUAL PENDANT HOLDER, 6977, REFURBISHED", "6977-710 - ACP HIP/THIGH PAD ASSY, LEFT, PRONE", "6988-758 - ProAxis Chest Pad", "7887-020R - LEVO LATERAL BASE, REFURBISHED", "5840-830R - ASSY, SPINAL TABLE TOP (500 LBS) REFURB.", "5855-612 - Trios/OTS PATIENT ISOLATION DRAPE RODS", "5855-61R - ASSY, CLAMP, REFURBISHED", "5873-300 - COUPLER II RADIOLUCENT DORO ADAPTER", "5880-09 - SHORT SUPINE OPERATING TOP", "6850-425 - PERINEAL POST EXTENDER", "6875-2740 - Hana Patient Transfer Board w/PAD", "6875-842i - DEMO UNIT, HANA AATHA, INTERNATIONAL", "6977-601 - HEAD SUPPORT ASSY", "6977R - Axis Table Top - Refurbished", "6988-900 - PROAXIS ACCESSORY CART", "7855-900R - ASSY, ORTHO TABLE TOP, REFURBISHED", "7887-080R - LEVO CONTROL HANDLES, REFURBISHED", "5010 - PREP-ASSIST", "5840-726 - MTS IMAGING TOP ASSEMBLY", "5847-04 - DRIVE SHAFT, TRANSVERSE PERINEAL POST", "5875-03 - MLPD BASE POST WITH LOCK SCREW 7\"", "5927-3000 - COVER, 5927 MODULAR IMAGING TABLE", "6836-8R - 8MM WELL HIP FIXATN FRM ASSY 6850 REFURB", "6850-2i - ASSY, BASE & TABLE TOP, ProFx INTL", "6850-486R - HANA/PROFX TRACTION BOOT LARGE (pr), REFURBISHED", "6875-3700 - HANA LEG SPAR LIFT ASSIST, RIGHT", "6875-601R - ASSEMBLY, FEMUR LIFT LH, REFURBISHED", "6879-10-1 - ASSY, SPAR MOUNT, SSXT, JP RAIL", "6977-886 - EMERGENCY CRANK, HINGE", "6988-880 - ProAxis Retractor Adapter", "7887-050 - Levo Arm", "7887-400 - Levo Premium Package", "5300 - Lateral Positioner", "5321GR - WILSON PLUS RADIOLUCENT FRAME REFURB", "5371 - ARTHROSCOPIC LEG HOLDER", "5847-249 - HIP LIFTER", "5848-241 - PRK PERINEAL POST TALL", "5855-838 - Well Leg Support", "5943-3000 - MTS Spinal Surgery Top Table Cover", "6300-93 - Hana/ProFx 90DEG PIN AND WIRE HOLDER", "6850-499 - BOOT SET, MODIFIED, X-LARGE, PAIR", "6850-94R - CRANK HANDLE ASSEMBLY, REFURBISHED", "6895-1345 - ADANTE SADDLE POST", "6895-92 - Adante Knee Pad Support Mount, Right", "6988-621 - ProAxis Foot-End Supine Top", "6988-90 - ProAxis Storage Rail Cover", "7803-349R - ASSY, IMAGING TABLE TOP, 650 LBS,REFURB.", "7887-803 - QuickConnect Radiolucent Mayfield Adapter", "FE00386 - BOOT LINER SET, LARGE", "5358 - ULTRA SHOULDER POSITIONER", "5840-24R - SUPPORT SECTION ASSY, REFURBISHED", "5840-740 - ARM BOARD MOUNTING BRACKET", "5855-519 - GM BOARD W/PAD, LEFT", "5864-3000 - COVER, 5864 MODULAR EQUIPMENT CART", "5875-07 - MLPD EXTENSION POST, 7\"", "6807-2R - HAND CONTROL, PROFX, REFURB", "6850-180 - Lateral Perineal Post Mount Bracket", "6850-413 - Hana/ProFx Adult Perineal Post", "6875-250 - Hana Lateral Perineal Post and Board", "6875-747 - HEAD END COMPLETE DRAPE RODS", "6977-570 - ARM BOARD ATTACHMENT ASSY", "7855-500R - CART, ORTHO EQUIPMENT, TRIOS,REFURBISHED", "7887-070 - LEVO PRONE PLATFORM", "3377S - PAD, SMALL MLPD BELLY, BLK", "5301R - DELUXE LATERAL, POSTIONER W/BALL JOINT, REFURBISHED", "5393 - Clark Socket", "5848-169 - LATERAL TRACTION BRACKET", "5855-7297 - PAD, TABLE, 5855 ORTHO TRAUMA TOP", "5855-900 - ASSY, ORTHO TABLE TOP (500 LBS)", "5927 - MTS Radiolucent Imaging Top", "5979-323 - ASSY, SWIVEL ADAPTER", "6837-10R - 10MM WELL HIP FIXTN FRM ASSY 6800 REFURB", "6850-7000R - ASSY, SPAR LIFT ASSIST DEVICE, REFURB", "6895-543 - Adante Supine Perineal Post", "6988-381 - PROAXIS TEMPUR-PEDIC HIP/THIGH PAD, LEFT", "7300 - Lateral Positioner Set", "7803-500 - Trios Equipment Cart w/Cover", "7887-300R - Levo Package 3: Standard, Refurbished", "7927R - Trios Imaging Top, Refurbished", "5840-361 - MTS T-Pin", "5840-830 - MTS SPINAL SURGERY FRAME", "5855-61 - Accessory Clamp", "5873-30 - SWIVEL ADAPTER ASSY, ALUMINUM", "5879-2 - ANTERIOR EXTENSION POSITIONER", "6850-2101 - LEG SPAR, LEFT", "6850-420 - Hana/ProFx 3in Extended Perineal Post", "6875-2730 - Hana Jack Mount Assembly", "6875-842 - DEMO UNIT, HANA AATHA", "6977-600R - FOOT SUPPORT ASSY, 6977, REFURBISHED", "6977-980 - ARM BOARD ASSY", "7855-900 - Trios ORTHOPEDIC TABLE TOP ASSEMBLY", "7887-080 - Levo Control Handles", "5357 - PIVOTING ARM BOARD W/TEMPUR 3IN", "5840-24 - SUPPORT SECTION ASSY.", "5840-735R - IMAGING TABLE TOP,500 LB,W/O PAD, REFURB", "5855-13R - TRACTION SLIDE ASSEMBLY, REFURBISHED", "5855-518 - GM BOARD W/PAD, RIGHT", "5864 - MTS Equipment Cart", "6807-2 - HAND CONTROL ProFx", "6850-170R - HANA/PROFX LOWER LEG SUPPORT, REFURBISHED", "6850-400 - Hana/ProFx Lateral Perineal Post", "6870-500R - CART, HANA SSXT, ASSESSORY REFURB", "6875-230 - Knee Flexation Device, Final Assembly", "6875-742 - Patient Transfer Assy", "6977-503 - Assembly, Chest Tray", "7855-500 - CART, ORTHO EQUIPMENT, TRIOS", "5840-277 - HEAD SUPPORT SECTION ASSEMBLY", "5840-7569 - PAD, CHEST, TEMPUR, SST", "5855-578 - Trios/OTS TRACTION EXTENSION SHORT", "5864R - MTS EQUIPMENT CART REFURB", "5875R - POSITIONER, LATERAL, MONTREAL, REFURBISHED", "6850-2 - ASSY, BASE & TOP, ProFx", "6850-413R - HANA/PROFX ADULT PERINEAL POST, REFURBISHED", "6875-264 - Hana/ProFx Femur Lift Extension", "6875-750 - Hana Foot-End Drape Rods", "6977-600 - FOOT SUPPORT ASSY", "6977-973 - UNIVERSAL SIDE RAIL ADAPTER 18 INCH", "7855-600 - Trios Orthopedic Traction Arc Cart", "7887-070R - LEVO PRONE PLATFORM, REFURBISHED", "5321G - WILSON PLUS RADIOLUCENT FRAME SPINE", "5579 - ARTICULATING ARM BOARD ASSEMBLY", "5840-389 - STS Cervical Traction Vector Adjustor", "5855-242 - Illlium Post Assembly", "5855R - ORTHOPEDIC TRAUMA TOP (500#), REFURB.", "5873-300R - COUPLER II RADIOLUCENT DORO ADAPTER, REFURBISHED", "6300-92R - ARTICULATING BRACKET, REFURBISHED", "6807-7R - HAND PENDANT, 6977, REFURB", "6844-315R - LEG BOARD EXTENSION W/PAD, REFURBISHED", "6850-2102 - LEG SPAR, RIGHT", "6873-1 - FEMUR LIFT ACCESSORIES KIT", "6875-5003R - SWITCH,FOOT,WIRED,LINAK CONN. REFURB.", "6977-4110 - CABLE, ROLL MOTOR (HEAD)", "7803-574R - ASSY, SPINAL TABLE TOP, 650 LBS, REFURB.", "7855R - ORTHOPEDIC TRAUMA TOP, TRIOS, REFURB.", "FE00384 - BOOT LINER SET, SMALL", "5275-5R - LEG ASSEMBLY, HAND SURGERY TABLE, REFURB", "5364 - Lateral Arm Board Unit w/Tempur 2in", "5847-175 - LOWER LEG SUPPORT ASSY", "5855-753R - WELL LEG LOWER SWING ARM, REFURBISHED", "5939-R - COMBO HIP/THIGH PAD, RIGHT", "6850-497 - BOOT SET, MODIFIED, SMALL", "6875-390R - SPAR, LEG, LEFT, RADIOLUCENT,REFURBISHED", "6895-1147 - Adante Traction Mount, Left", "6895-91 - Adante Knee Mount, Right", "6977-959R - UNIVERSAL SIDE-RAIL ADAPTER, REFURBISHED", "6988-530 - ProAxis Articulating Arm Board w/Tempur", "6988-899 - ProAxis Rail Mount Left", "7803-320 - Trios Radiolucent Imaging Top Cover", "7887-802 - QuickConnect Radiolucent DORO Adapter", "3368 - Hana/ProFx 3IN SHORTENED PERINEAL POST", "5840-831R - ASSY, SPINAL TABLE TOP (500 LBS) REFURB.", "5847-320 - PRK PERINEAL POST", "5855-617 - Trios/OTS FOOT-END DRAPE HANGER POST", "5855-672 - Traction Tube Clamp Assembly Left", "5888R - ADAPTER, RETRACTOR, SPINAL TOP, REFURB", "6850-430 - PRONE SKELETAL TRACTION HOLDER", "6850-520 - ProFx CART", "6875-2761R - HANA FRACTURE KIT, REFURBISHED", "6875j - TABLE, HANA, 100V JAPAN", "6895-45 - ADANTE TRACTION BOOT, SMALL, PAIR", "6987R - Assembly, Hand Pendant, ProAxis, Refurb", "6988-945 - TORSO TROLLEY, CHEST TRAY", "7887-100R - Levo Package 1: Prone, Refurbished", "3369 - Hana/ProFx Large Diameter Perineal Post", "5300-70 - PUBIC POSITIONER ASSY, ROUND PAD", "5846 - Coupler II STS Brackets (PR)", "5847-95 - PRK PIN AND WIRE HOLDER ASSY", "5855-672R - TRACTION UNIT UPRIGHT, LEFT, REFURBISHED", "5890-81 - TABLETOP SUPPORT ASSEMBLY", "5979-200R - Radiolucent Mayfield Adapter Assy, 5979 REFURB", "6850-450 - TRACTION HOOK EXTENDER", "6850-6001 - AUXILIARY IMAGING TOP", "6875R - TABLE, HANA, 110 V, REFURBISHED", "6895-46 - ADANTE TRACTION BOOT, LARGE, PAIR", "6988 - TABLE, ProAxis", "6988-969 - CERVICAL CHEST TRAY ASSY 1.2", "7887-200 - Levo Cervical Package", "7927 - TRIOS, TOP, RADIOLUCENT IMAGING", "5840-831 - ASSY, SPINAL TABLE TOP, 500LBS", "5855-615 - Trios/OTS HEAD-END DRAPE HANGER POST", "5855-644 - Trios/OTS LEG SPAR UPRIGHT", "5888 - Trios/STS Retractor Adapter", "6850-425R - PERINEAL POST EXTENDER, REFURBISHED", "6875-2761 - PKIT, FRACTURE, HANA", "6875I - Hana Orthopedic Surgery Table (int'l)", "6895-2190 - ADANTE ADAPTER, MAI CLARK SOCKET", "6977-601R - HEAD SUPPORT ASSY, REFURBISHED", "6987 - ASSEMBLY, HAND PENDANT, ProAxis", "6988-900R - ProAxis Accessory Cart REFURB", "7887-100 - Levo Prone Package", "5338-70R - ARMBOARD,TRANSLATE,ULTRA SHOULDER,REFURB", "5376R - ASSEMBLY, TRANSLATING, ARMBOARD, REFURB", "5803R - ADVANCED CONTROL I-BASE, DC, REFURBISHED", "5855-13 - TRACTION SLIDE ASSEMBLY", "5855-411R - TIBIA TRACTION UPRIGHT, REFURBISHED", "5855-865 - TRACTION BOOT W/PLATE XLARGE LT RT", "5862 - KIRSCHNER BOW HOLDER", "6800-350R - DRAPE ROD, REFURBISHED", "6850-165 - ANGLED AUXILIARY CLAMP, LEFT", "6870-29 - UPRIGHT ASSEMBLY, NON-OPERATIVE LEG", "6875-200R - WELL LEG SUPPORT ASSEMBLY, REFURBISHED", "6956 - Trios/STS Pad Set Tempur Comfort (8pc)", "6977-501R - RAIL ASSEMBLY, RIGHT, REFURBISHED", "7803-471R - ASSY, COUPLER, FULL, REFURBISHED", "7803R - TRIOS, TABLE BASE, REFURBISHED", "5579R - ARTICULATING ARM BOARD ASSEMBLY, REFURB", "5840-450 - SLING, LEG", "5855-271 - Trios/OTS CHILD PERINEAL POST W/PAD", "5857 - Cross Arm Support w/Pad", "5873-31 - SWIVEL ADAPTER ASSY, RADIOLUCENT", "6835-10 - MTS WELL HIP FIXATION FRAME (10mm)", "6850-103 - TRACTION LIFTER BRACKET", "6850-2102R - SPAR ASSEMBLY, RIGHT, REFURBISHED", "6873-10 - SPAR MOUNT ASSEMBLY, SSXT, AUS 777", "6875-5005 - HANA FEMUR LIFT FOOT PEDAL", "6977-4130 - HINGE MOTOR CABLE", "6977-640 - COLUMN SLIDER ASSY, FOOT END", "7803-579 - RATCHET TOWER", "7887-010 - Levo Dual Motion Base", "3377L - PAD, LARGE MLPD BELLY, BLK", "5301 - Deluxe Lateral Positioner Set", "5379-35 - ARTICULATING ARMBOARD UPRIGHT", "5846R - BRKT,ADAPTOR,SPINAL,5873/5850, PR,REFURB", "5848-124 - COUNTER TRACTION POST ASSY", "5855-673R - TRACTION UNIT UPRIGHT, RIGHT, REFURBISHED", "5899-6 - TRACTION UNIT UPRIGHT ASSEMBLY", "5979-300R - ADAPTER, RADIOLUCENT DORO, 5979, REFURB", "6837-10 - 10MM WELL HIP FIXATION FRAME (6800)", "6850-485 - Hana/ProFx Traction Boot Small (pr)", "6850-7000 - ProFx Spar Lift Assist", "6895-501 - Adante Pelvic Center Board", "6988-209R - ProAxis Cervical Mgmt Mounting Bracket REFURB", "6988R - ProAxis, REFURBISHED", "7887-300 - Levo Standard Package", "7927-959R - ADAPTER, UNIVERSAL, SIDE-RAIL, REFURB", "3369R - PERINEAL POST, LARGE DIAMETER, REFURB", "5300R - Lateral Positioner, Refurbished", "5846-5 - Coupler II STS Brackets", "5848 - MTS Pelvic Reconstruction Kit", "5855-673 - Traction Tube Clamp Assembly Right", "5899-5 - TRACTION LOAD SCALE ASSEMBLY", "5979-300 - CMBU RADIOLUCENT DORO ADAPTER", "6850-480 - TRACTION LIFTER", "6850-6001R - AUXILIARY IMAGING TOP, REFURBISHED", "6875SC - HANA SC SURGERY CENTER TABLE", "6895-47 - ADANTE TRACTION BOOT, EX LARGE, PAIR", "6988-209 - ProAxis Cervical Mgmt Mounting Bracket", "6988i - ProAxis Spinal Surgery Table (int'l)", "5319-6 - HANDLE, CRANK W/ TORQUE LIMITER", "7887-200R - Levo Package 2: Cervical, Refurbished", "5394 - ALUMINUM SIDE RAIL SOCKET", "7927-959 - Trios Side Rail Adapter 6in", "5848-172 - ASSY, TRACTION/LIFTER", "5855-14 - Soft Traction Boot Large", "5855-752 - Trios/OTS Radiolucent Auxiliary Leg Spar", "5855-911 - Trios/OTS Patient Transfer Board", "6300-420 - DRAPE HANGER TOP RAIL, FOOT END", "6837-8R - 8MM WELL HIP FIXTN FRM ASSY 6800 REFURB", "6850-7570 - PAD, TABLE, MAIN, 6850 ProFx", "6870-6 - ASSEMBLY, LEG SPAR", "6895-70 - Adante FlexLation Spar, Left", "6956-6 - THIGH PAD, TEMPUR PEDIC COMFORT, RIGHT", "7802R - HANDPENDANT,RECONDITIONED,TRIOS, REFURB.", "7803-509 - COVER, EQUIPMENT CART, TRIOS", "7943R - Trios Spinal Top, Refurbished", "5605 - ARTHROSCOPIC STRESS POST W/PAD", "5840-580 - CHEST SUPPORT SECTION ASSY.", "5855-3000 - COVER, 5855 ORTHOPEDIC TRAUMA TOP W/O ARC", "5857R - CROSS ARM SUPPORT W/PAD, REFURBISHED", "5873R - ASSY,COUPLER II,MAYFIELD HEADREST,REFURB", "6835-8 - MTS WELL HIP FIXATION FRAME (8mm)", "6850-110 - Hana/ProFx Femoral Hook Support", "6850-25 - Tibial Traction Boot Adapter", "6873-41 - HAND CRANK ASSEMBLY", "6875-292 - HANA ARMBOARD", "6875-500R - ASSEMBLY, HANA CART, REFURBISHED", "6977-4140 - ELEVATOR MOTOR CABLE", "6977-640R - COLUMN SLIDER ASSY FOOT END, 6977,REFURB", "7803-579R - ASSY, ADJUSTABLE TABLE MOUNT 7803,REFURB", "7887-010R - LEVO DUAL MOTION BASE, REFURBISHED", "5300-39 - PUBIC POSITIONER ASSY", "5338-24 - ULTRA SHOULDER POSITIONER CART", "5376 - TRANSLATING ARM BOARD ASSEMBLY", "5803i - Advanced Control I-Base DC International", "5855 - MTS Orthopedic Trauma Top", "5855-863 - TRACTION BOOT WSWIVEL SM, PLATE, LF & RT", "5859-3000 - COVER, 5859 ORTHO EQUIPMENT CART", "5979-200 - CMBU RADIOLUCENT MAYFIELD ADAPTER", "6310-111 - TRACTION BOOT & PLATE, LARGE, LT & RT", "6850-123 - HOOK AND BOW ASSEMBLY", "6870-103 - SADDLE ASSEMBLY, TRACTION LIFTER", "6896 - Adante IntelliTouch Hand Pendant", "6988-720 - ProAxis Cervical Traction Vector Short", "7803-456R - TRIOS CMBU ADAPTER BRACKET REFURB", "7803-757 - ASSY, PUBIC POSITIONER", "7887-840 - CONTOURED CHEST PAD, TEMPUR PEDIC", "5338-70 - TRANSLATING ARM BOARD ASSY, FOR 5338", "5376-1 - TRANSLATING ARM BOARD", "5803j - ADVANCED CONTROL I-BASE, DC, JAPAN", "5855-120 - Trios/OTS 90deg Pin and Wire Holder", "5855-864 - TRACTION BOOT WSWIVEL FT.PLATE LG,LF,RT", "5859R - ORTHOPEDIC EQUIPMENT CART, REFURBISHED", "6310-112 - TRACTION BOOT & PLATE, X-LARGE, LT & RT", "6850-126 - LATERAL PERINEAL SUPPORT ASSY", "6870-2 - FEMUR LIFT ACCESSORIES KIT", "6900-20R - SIDE RAIL CLAMP 6 IN., REFURBISHED", "6977-501 - RAIL ASSEMBLY, RIGHT", "6988-720R - ProAxis Cervical Traction Vector Short REFURB", "7803-457R - ADAPTER, CERVICAL MANAGEMENT, REFURB", "7803-790 - CERVICAL TRACTION VECTOR ADJUSTER", "5356R - ARMBOARD, PIVOTING W/2\" PAD, REFURB", "5839 - A/P CASSETTE TRAY (STS-2000)", "5855-137 - Trios/OTS Lateral Perineal Post", "5855-440R - FOOT PLATE ASSY, REFURBISHED", "5863-3000 - COVER, 5863 ORTHO TRACTION ARC CART", "6807-1R - HAND PENDANT, ADVANCED CONTROL BASE", "6850-170 - Hana/ProFx LOWER LEG SUPPORT", "6870-500 - CART, HANA SSXT, ASSESSORY", "6875-209 - ASSEMBLY FOOTPLATE KNEE FLEXATION", "6875-602R - FEMUR LIFT EMERGENCY CRANK HANDLE,REFURB", "6956-4 - HIP PAD, TEMPUR PEDIC COMFORT, MEDIUM", "6977-502R - RAIL ASSEMBLY, LEFT, REFURBISHED", "7855-13 - Trios Traction Arc", "5275R - RADIOLUC HAND SURGERY TABLE W/PAD,REFURB", "5364R - ARMBOARD UNIT, LATERAL, REFURBISHED", "5847-193 - PRK BOW ADAPTER", "5848-240 - FIXED PERINEAL POST MOUNT, TALL", "5855-76 - Trios/OTS Lower Leg Support", "5943 - MTS Spinal Surgery Top", "6850-498 - BOOT SET, MODIFIED, LARGE", "6850-94 - U HANDLE CRANK", "6875-399 - TRACTION HOOK EXTENSION", "6895-1148 - Adante Traction Mount, Right", "6895-910 - Adante Knee Foot Support", "6988-540 - FLAT CHEST PAD, NON-ACP", "6988-899R - ProAxis RAIL MOUNT LEFT,6988,REFURBISHED", "7803-349 - Trios Imaging Table Top Assembly", "7887-802R - QUICKCONNECT RADIOLUCENT DORO, REFURB", "5319G - WILSON PLUS UNIVERSAL W/TEMPUR PADS", "5394R - SOCKET, ALUMINUM, SIDE RAIL, REFURBISHED", "5848-191 - PELVIC ARC ASSEMBLY", "5855-15 - Soft Traction Boot Small", "5855-752R - RADIOLUCENT LEG SPAR, REFURBISHED", "5855-920 - PERINEAL POST, ADULT W/PAD", "6300-421 - DRAPE ROD", "6807-4 - HAND PENDANT, HANA", "6844-132 - INSITE CERVICAL CROSSBAR", "6850-80 - ACCESSORY ATTACHMENT BRACKET", "6870-7 - ASSEMBLY, TRACTION SPAR", "6895-71 - Adante FlexLation Spar, Right", "6956-7 - THIGH PAD, TEMPUR PEDIC COMFORT, LEFT", "7803 - TRIOS, TABLE BASE", "7803-514 - Side Rail Adapter 18in", "904 - TRACK RACK", "5840-620 - TRIOS/STS, DUAL CHEST PADS, 1/PR", "5847-02 - TRANSVERSE PERINEAL POST MOUNT", "5855-411 - TIBIA TRACTION UPRIGHT", "5875-02 - MLPD BASE POST W/LOCK SCREW, 5\"", "6836-8 - 8mm WELL HIP FIXATION FRAME ASSY (6850)", "6850-280 - WELL LEG SUPPORT ARM", "6850-486 - Hana/ProFx Traction Boot Large (pr)", "6875-200 - Hana Well Leg Support Adapter", "6875-370 - Radiolucent Leg Spar Right", "6875-601 - Hana FEMUR LIFT ASSY, LH", "6877-10 - ASSY, SPAR MOUNT, SSXT DENYERS 5000", "6977-720 - ACP HIP/THIGH PAD ASSY, RIGHT, PRONE", "6988-80 - DUST COVER, CART", "7887-030R - LEVO Z TOWER, REFURBISHED", "5300-2 - SHOULDER & SACRAL POSITIONER ASSY", "5338-18 - SECURING STRAP", "5372 - LEG HOLDER, EXTENDED ARTHROSCOPIC", "5803 - ADVANCED CONTROL I-BASE, DC", "5847-301 - FOOT SUPPORT ASSEMBLY", "5848R - MTS Pelvic Reconstruction Kit, Refurbished", "5855-838S - WELL LEG SUPPORT, SHORT", "5979-1R - CERVICAL MANAGEMENT BASE UNIT, REFURB", "6310-110 - TRACTION BOOT & PLATE, SMALL, LT & RT", "6850-114 - Hana/ProFx Traction Device Hook", "6850-510 - ARM SUPPORT ASSEMBLY", "6870-10 - ASSY, SPAR MOUNT, SSXT", "6895AX-00 - Adante AX Orthopedic Surgical Platform", "6988-70 - ProAxis Table Cover", "7803-456 - TRIOS CMBU ADAPTER BRACKET", "7887-831 - RAISED CHEST SUPPORT PLATE", "NV1705 - Adante Wireless Foot Pedal", "5840-600 - DUAL CHEST PAD, RIGHT", "5855-319 - CENTER SUPPORT BOARD ASSEMBLY", "5859 - ORTHOPEDIC EQUIPMENT CART", "5875 - POSITIONER, LATERAL MONTREAL", "6836-10 - 10mm WELL HIP FIXATION FRAME (6850)", "6850-27 - ProFx Traction Boot Adaptor Assy", "6875 - TABLE, HANA, 110 V", "6875-326 - REPLACEMENT HANA BASE ASSY, 110V", "6875-600 - Hana FEMUR LIFT ASSY, RH", "6977-4162 - Dual Pendant Holder", "6977-641 - COLUMN SLIDER ASSY, HEAD END", "6988-725 - ProAxis Cervical Traction Vector Long", "7803-756 - ASSY, SHOULDER & SACRAL POSITIONER", "7887-020 - LEVO LATERAL BASE", "5319-37 - PAD SET WILSON FRAME TEMPUR PEDIC", "5393R - CLARK SOCKET, REFURBISHED", "5848-170 - CLAMP ASSY, ELEVATOR", "5855-7377 - PAD, TRANSFER, 3\"", "5855-900R - ASSY, ORTHO TABLE TOP, 500 LB REFURBISHED", "6300-416 - DRAPE HANGER UPRIGHT", "6837-8 - 8MM WELL HIP FIXATION FRAME (6800)", "6850-7560 - PROFX PELVIC PAD", "6895-560 - Adante Knee Extension Board", "6956-5 - HIP PAD, TEMPUR PEDIC COMFORT, SMALL", "6988-389 - PROAXIS TEMPUR-PEDIC HIP/THIGH PAD, RIGHT", "7802 - ASSEMBLY, HAND PENDANT, TRIOS", "7803-500R - CART, EQUIPMENT, 7803, REFURBISHED", "7943 - Trios Spinal Surgery Top", "5319GR - WILSON PLUS UNIVERSAL, REFURB", "5398 - COMBO CLAMP ASSY", "5848-220 - FIXED PERINEAL POST MOUNT", "5855-163 - Trios/OTS Leg Board", "5855-925 - Trios/OTS Adult Perineal Post w/Pad", "6300-430 - DRAPE HANGER TOP RAIL, HEAD END", "6807-4R - HAND PENDANT, HANA, REFURBISHED", "6844-132R - ASSEMBLY, CERVICAL LINKEAGE BAR, REFURB", "6850-80R - ASSY, BRACKET, ACCESS ATTACHMENT, REFURB", "6870-90 - FEMORAL HOOK SUPPORT, SSXT", "6875-399R - TRACTION HOOK EXTENSION, REFURBISHED", "6895-90 - Adante Knee Mount, Left", "6977-4005i - CONTROL BOX W/MOUNTS, 230 V", "7803-514R - SIDE RAIL ADAPTER 18IN REFURB", "973 - Inflatable Bladder (6x10in)", "5275 - RADIOLUCENT HAND SURGERY TABLE W/PAD", "5358R - ULTRA SHOULDER POSITIONER,REFURBISHED", "5840-735 - IMAGING TABLE TOP, 500 LB, W/O PAD", "5847-07 - PELVIC RECONSTRUCTION KIT CART", "5875-05 - MLPD EXTENSION POST, 5\"", "5939 - Combination Hip/Thigh Pad Set", "6850-3010 - COVER, PROfx TABLE ACCESSORY CART", "6850-487R - HANA/PROFX TRACTION BOOT XLARGE (pr), REFURBISHED", "6875-390 - Radiolucent Leg Spar Left", "6895-1060 - Adante Femur Lift", "6977-939R - RETRACTOR ADAPTOR, REFURBISHED", "6988-449R - RETRACTOR ADAPTOR, RADIOLUCENT, REFURB", "6988-887 - ProAxis Rail Mount Right", "7887-060 - Levo Z Tower", "7887-801 - QuickConnect Aluminum Skull Clamp Adapter" ], "establishment_type": [ "Manufacture Medical Device" ], "registration": { "registration_number": "2921578", "fei_number": "2921578", "status_code": "1", "initial_importer_flag": "Y", "reg_expiry_date_year": "2026", "name": "MIZUHO ORTHOPEDIC SYSTEMS, INC.", "address_line_1": "30031 AHERN AVE", "address_line_2": "", "city": "UNION CITY", "state_code": "CA", "iso_country_code": "US", "zip_code": "94587", "postal_code": "", "us_agent": {}, "owner_operator": { "firm_name": "Mizuho Orthopedic Systems, Inc.", "owner_operator_number": "2921578", "official_correspondent": { "first_name": "Krina", "middle_initial": "-", "last_name": "Shah", "subaccount_company_name": "", "phone_number": "1-510-4291500-x" }, "contact_address": { "address_1": "30031 Ahern Avenue", "address_2": "--", "city": "Union City", "state_code": "CA", "state_province": "", "iso_country_code": "US", "postal_code": "94587" } } }, "pma_number": "", "k_number": "", "products": [ { "product_code": "JEA", "created_date": "1999-08-03", "owner_operator_number": "2921578", "exempt": "", "openfda": { "device_name": "Table, Surgical With Orthopedic Accessories, Ac-Powered", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4960", "device_class": "1" } } ] } ] }