{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Long Probe",
        "Femoral Locator",
        "Chondral Pick",
        "Blunt Nose Junior",
        "MegaMouth Grasper",
        "Bone Tap",
        "Cannula Driver",
        "Hammerhead Rotary Punch",
        "Hammerhead Rotary Scissor",
        "Graft Assist, Board",
        "Tapered Tap",
        "Depth Probe",
        "Jaws Tigar Shark Grasper",
        "Suture Hook",
        "Clearcut Suture Cutter",
        "ACL Tunnel Rasp",
        "N8TIVE ACL Curette",
        "Titan Removal Tool Capture Sleeve",
        "Graft Board Hook",
        "Graft, Base Lock",
        "Single Hole Knot Pusher",
        "Beluga Retro",
        "Crochet Hook",
        "N8TIVE ACL Depth Gage",
        "A-Tech Femoral Locator Handle",
        "Closed Tendon Harvester",
        "Removal Tool Driver; MTO DRIVER 3.5MM 1.5MM CANN W/HUD ADAP; MTO DRIVER BIORCI W/HUDSON ADAPTOR",
        "Ankle Distractor Strap",
        "Meniscal Lift",
        "Graft Bar Holder",
        "N8TIVE ACL Tibial Dilator",
        "N8TIVE ACL Femoral Drill Guide Trocar",
        "Point to Point, ACL Arm",
        "Manta",
        "N8TIVE ACL Disposables Kit",
        "ACL Disposables Guidewire Kit",
        "Tunnel Notcher",
        "Graft, Tissue Clamp",
        "Transverse Arm",
        "Titan Bone Punch",
        "Meniscal Rasp",
        "Radial Clamp",
        "Slotted Tendon Harvester",
        "Piranha Junior",
        "Universal Rachet Handle",
        "Point to Elbow, ACL Arm",
        "ACL Open Curette",
        "N8TIVE ACL Tibial Button Impactor",
        "ACL Disposables Kit",
        "Piranha Arthroscopic Rongeur",
        "ACL Closed Curette",
        "Bilok ST Graft Expander",
        "Tunnel Expander",
        "Swordfish",
        "Lobster Claw Suture Retriever",
        "Jaws Great White Grasper",
        "N8TIVE ACL Tibial Sheath Inserter",
        "Cuff Elevator",
        "N8TIVE ACL Tendon Harvester",
        "N8TIVE ACL Tunnel Rasp",
        "Elevator Rasp",
        "Cannulated Switching Stick",
        "N8TIVE ACL Graft Sizing Block",
        "TRIGEN",
        "Toothless Shark Atraumatic Grasper",
        "Ankle Distractor",
        "Tibial Tunnel Plug",
        "Transverse Bullet",
        "A-Tech Controlled Flexion Guidewire",
        "Marlin",
        "Metal Screw Driver Shaft",
        "Jaws Retro Junior Grasper",
        "Guidewire Aimer",
        "JOURNEY",
        "Probe",
        "Multi-Sizing Block",
        "Slap Hammer",
        "Passing Pin Puller",
        "ACL Bullet",
        "Adaptor",
        "Wissinger Rod",
        "Suture Clamp Tension meter",
        "Jaws Retro Toothed Grasper",
        "Graft, Suture Clamp",
        "Femoral Aimer",
        "Small Joint Probe",
        "PERI-LOC",
        "REFLECTION",
        "EMPERION",
        "Inserter Tip",
        "Rotation Medical Arthroscopic Instrument Kit",
        "TANDEM",
        "Rotation Medical Mini-Open Instrument Kit",
        "Accu-Pass Suture Shuttle, Monoflement Size No. 1, Single Pack, Sterile - 72201361",
        "GENESIS",
        "Glenoid Holder",
        "TIBIAXYS",
        "PANTA",
        "LABELS FOR RING MODULE",
        "Accu-pass suture shuttle, crescent, 7210427",
        "Biosure Guide Wire, 1.2mm x 9 inch, Box of 5, Sterile",
        "Arthroscopic needle, 72202825",
        "QWIX",
        "Pin Puller",
        "Endobutton Pin Passing 2.4mm Trocar",
        "Accu-pass suture shuttle 45 degree up, 7210425",
        "Surgical Instrument - Planer",
        "LARGE QWIX",
        "Surgical Instrument - Driver",
        "Wire and pin pac, 7207738",
        "Guidewire 2.4mm Drill Tip, guide wire, 12\", 7207221",
        "guide wire 2mm",
        "Twinfix AB 6.5mm threaded dilator, 72200820",
        "Suretac 6mm Guidewire, 72202809",
        "Accu-pass suture shuttle right 45 degree",
        "Accu-pass suture shuttle, Big Curve",
        "Wire and pin pac (C)",
        "PCL Guidewire, 7207284",
        "Guidewire 1.5mm x 229mm",
        "Round Oval Sizing Guide",
        "Wire and pin pac (B)",
        "1.5mm Guidewire, 12\", 72202189",
        "Cannuflex 9\" Blunt Guidewire, 72202807",
        "Accu-pass suture shuttle, straight, 7210426",
        "Guide wire 2mm, 15\", 7207222",
        "Biosure 1.2mm x 18\", 72201201",
        "Awl tapered 3.8mm",
        "Pliers, Compaction, 9MM",
        "Guidewire, Nitinol 1.2mm x 45cm",
        "Accu-pass suture shuttle 70 degree, Upbend, 72200419",
        "Twinfix AB 5mm threaded dilator, 72200819",
        "Passing pin Spade tip 3mm, 72202814",
        "Beath pin 2.4mm, 72202815",
        "Awl straight 3.8mm, 72202986",
        "Accu-pass suture shuttle left 45 degree, 7210423",
        "Extremities Guide, Universal",
        "TENDON STRIPPER CLOSED",
        "SWISS RAIL CLAMP (LATERAL DSTRCTR SYS)",
        "US SUPINE RAIL CLAMPS 2, 0.375 INCH X 1.125 INCH 1 CM X 2.9 CM",
        "ARTHROSCOPIC NEEDLE STERILE",
        "RCI 8 MM FEMORAL STEPPED ROUTER",
        "UNIVERSAL HIP DISTRACTOR WITH LEATHER BOOT",
        "TENDON STRIPPER, SLOTTED, 5 MM I.D. X 12 INCH WORKING LENGTH",
        "WELL LEG HOLDER WITH LEATHER BOOT",
        "Awl, tap, driver, dilator",
        "ACCU-PASS SUTURE SHUTTLE, MONOFILAMENT SIZE No.1, SINGLE PACK, STERILE",
        "KNEE HOLDER",
        "8MM BICEPTOR TAP",
        "GUIDEWIRE CANNFLEX 9 BLUNT TIP",
        "RCI 7.5 MM FEMORAL STEPPED ROUTER",
        "SWISS RAIL CLAMP (SUPINE DSTRCTR SYS)",
        "BOARD, PATIENT TRANSFER",
        "SCREW GUIDE WIRE, 2 MM X 12 INCH 30CM, BLUNT TIP, STERILE 6 PER PACKAGE",
        "GUIDE WIRE PCL 2.4MM X10",
        "LOOP TIP GUIDEWIRE",
        "TWINFIX AB 5 THREADED DILATOR",
        "6.5 MM DILATOR",
        "LARGE INSERTER DSP",
        "HAMMER SLAP DILATOR SYSTEM",
        "4 MM ANTI-IMINGEMENT DEVICE, USED WITH 7 MM AND 8 MM GRAFTS",
        "5 MM ANTI-IMPINGEMENT DEVICE, USED WITH 9 MM AND 10 MM GRAFTS",
        "7MM TENDON FORK",
        "PASSING PIN, 3 MM, SPADE TIP",
        "RCI 7.5 MM TIBIAL STEPPED ROUTER",
        "ACCUPASS STR SHUTL MONOFIL -SEE72201361",
        "8MM DILATOR",
        "RCI 8.5 MM TIBIAL STEPPED ROUTER",
        "GD WIRE NITINOL 1.2 X 45CM",
        "MTO,SCRW DRVR,LOCKING, 2.5MM HEX, CANN",
        "LOCKING WRENCH",
        "MTO GUIDEWIRE THREADED 1.5MM X 45CM",
        "10MM DILATOR",
        "6.5MM DILATOR",
        "DIRECTOR PCL ELEVATOR WITH WIRE CATCHER",
        "TROCAR-TIP PASSING PIN, 2.4 MM X 17 INCH, STERILE",
        "MTO TWINFIX ULTRA 5.5 FOR 5.5 CANNULA",
        "BI-GRIP PIN PULLER",
        "RCI 7 MM FEMORAL STEPPED ROUTER",
        "Drill for Q-FIX with Needles",
        "ACCU-PASS SUTURE SHUTTLE 70 DEGREE",
        "RCI 8.5 MM FEMORAL STEPPED ROUTER",
        "12MM DILATOR",
        "STITCHER",
        "RCI 7 MM TIBIAL STEPPED ROUTER",
        "Rotation Tendon Marker",
        "DENYER RAIL CLAMP (LATERL DSTRCTR SYS)",
        "RCI 8 MM TIBIAL STEPPED ROUTER",
        "2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE",
        "ARTHROPIERCE XL STRAIGHT",
        "6MM DILATOR",
        "WHIPKNOT SOFT TISSUE CINCH 5 SUTURE",
        "ACCU-PASS STR SHTL BIG C STERILE BOX 1",
        "4.5 MM DILATOR",
        "LARGE TENDON STRIPPER, CLOSED, 7.4 MM I.D. X 13.5 INCH WORKING LENGTH",
        "REPLACEMENT LEATHER BOOT 1",
        "7MM BICEPTOR TAP",
        "PERINEAL POST",
        "DENYER SUPINE RAIL CLAMPS 2",
        "3.5 MM DILATOR",
        "OPEN CURETTE 6MM REVERSE CUT XL",
        "8.5MM DILATOR",
        "MTO AWL-DIL TF ULTRA 5.5/6.5 CORTICAL",
        "MAVERICK MINI",
        "8MM TENDON FORK",
        "GUIDE WR 1.2MM X 12 BOX OF 5 STERILE",
        "SCREW GUIDE WIRE, 1.5 MM X 12 INCH 30 CM, BLUNT TIP, STERILE",
        "TWINFIX 3.8 MM STRAIGHT AWL, REUSABLE",
        "US LATERAL RAIL CLAMP 2",
        "GUIDE WIRE BEATH PIN 2.4 MM STERILE",
        "Tendon Stabilizing Guide",
        "SUTURE NEEDLE SHUTTLE STERILE",
        "BIORAPTOR KNOTLESS INLINE DRILL GUIDE, SPIKE TIP",
        "rail clamp, passing pin",
        "MTO GUIDE WIRE AC JOINT 2.4 MM",
        "AWL STRAIGHT 3.8MM DISPOSABLE",
        "GUIDE WIRE 1.2MM X18 BX OF 5 STER.",
        "9MM DILATOR",
        "GUIDE WIRE 1.2MM X 9 BOX OF 5 STERILE",
        "1.5 MM TENDON DRILL PIN",
        "EUR/UK LATERAL RAIL CLAMPS 2 0.394 INCH X 0.984 INCH",
        "EUR/UK RAIL CLAMP (LATERL DSTRCTR SYS)",
        "SUPINE TABLE ATTACHMENT PAD",
        "RCI 6.5 MM TIBIAL STEPPED ROUTER",
        "7MM DILATOR",
        "OPEN CURETTE 4.5MM XL",
        "11MM DILATOR",
        "TWINFIX AB 6.5 THREADED DILATOR",
        "SMALL INSERTER DSP",
        "9MM TENDON FORK",
        "MANUAL INSTRUMENT TRAY",
        "8.5 MM DILATOR",
        "RCI 6.5 MM FEMORAL STEPPED ROUTER",
        "CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 15 INCH 38 CM, BLUNT TIP, STERILE",
        "MTO AWL-DILATOR TF ULTRA 4.5 CORTICAL",
        "STYLET FOR STITCHER",
        "TruKor Gauge",
        "2.7 MM DILATOR",
        "KNOT PUSHER XL",
        "9.5MM DILATOR",
        "PLIERS, COMPACTION, 9mm",
        "7.5MM DILATOR"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3026368553",
        "fei_number": "3026368553",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "INTEGRITY ORTHOPAEDICS, INC.",
        "address_line_1": "5565 Pioneer Creek Drive",
        "address_line_2": "",
        "city": "Maple Plain",
        "state_code": "MN",
        "iso_country_code": "US",
        "zip_code": "55359",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "Smith & Nephew, Inc.",
          "owner_operator_number": "1020279",
          "official_correspondent": {
            "first_name": "Lisa",
            "middle_initial": "",
            "last_name": "Ewing",
            "subaccount_company_name": "",
            "phone_number": "x-412-4199765-x"
          },
          "contact_address": {
            "address_1": "2875 Railroad Street",
            "address_2": "",
            "city": "Pittsburgh",
            "state_code": "PA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "15222"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "LXH",
          "created_date": "2006-10-05",
          "owner_operator_number": "1020279",
          "exempt": "",
          "openfda": {
            "device_name": "Orthopedic Manual Surgical Instrument",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.4540",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}