{ "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": 2 } }, "results": [ { "proprietary_name": [ "UNIVERSAL PIN-WIRE CASE", "ANCHORAGE PLATE BENDER", "BIOCOMPRESSION WRENCH 20mm TUBE", "ANCHORAGE FIXATION PIN", "HOFFMANN LRF SPANNER WRENCH - 5 mm", "HOFFMANN LRF WIRE BOLT WRENCH", "LID FOR PLATE RACK - COMPRESSION PLATES", "CURSOR", "TRAY FOR MV SCREWS", "SMALL RULER FOR MEASUREMNET", "HOFFMANN XPRESS TORQUE WRENCH", "PROTRACTOR", "M/T TRIAX LNG HANDLE WRENCH RED", "KW BENDING IRON ICS", "TRIAL ANCHORAGE PLP11341", "HII TRAY BASE", "HII MICRO NUT DRIVER", "4mm DBL SLEEVE 150mm TROC/ASSY", "HOFFMANN XPRESS STORAGE CASE LID", "HII MICRO STORAGE CASE DRILL BIT HOLDER", "OMEGA PLUS DRILL GUIDE HANDLE", "HOFFMANN LRF UNIVERSAL COMPONENTS INSERT", "RACK FOR PLP UTILITY/MTP (LEVEL 2)", "OMEGA PLUS TAP GUIDE 4.5mm", "APEX TRAY BASE", "TENSION DEVICE 16MM", "9mm SUBFIX TRIAL", "DEPTH GAUGE (DISTAL RADIUS)", "TRIAL ANCHORAGE PLP30142", "DRILL GUIDE BLOCK COMPACT PERI 4 HOLE", "OMEGA+ VAR ANGLE GUID REPL KIT", "DEPTH GAUGE (HAND)", "APEX DRILL BRACE - 3/4/5/6mm", "SMART TOE 1 INSTRUMENT KIT", "HOFFMANN LRF UNIVERSAL COMPONENTS TRAY", "AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK", "RED & BLUE INTL M/T CASE", "HII COMPACT STORAGE CASE UPPER INSERT", "AO HANDLE - LENGTH 135MM", "AO/JACOBS QUICK RELEASE APEX CHUCK 3mm", "HII MICRO STORAGE CASE LOWER INSERT", "AGM 6 6MM CHUCK", "6mm PREDRILL ASSEMBLY EXTRA SHORT", "AEQ TIGE FRA LG FANT", "AEQ USA FANT CALO", "STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2MM", "TRIAL ANCHORAGE PLP30141", "TRAY", "HOFFMANN LRF THUMBWHEEL - HEX 10", "HII COMPACT MRI STORAGE CASE UPPER INSERT", "OMEGA PLUS HEAD", "Graft box wedge", "Graft box washer", "INTERMEDIATE PROSTHESIS HOLDER RIGHT", "TRIAL ANCHORAGE PLP40460", "OMEGA PLUS LAG SCREW ADAPTER", "STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2.5MM", "PIN CUTTER / HA PINS", "HII 7mm T-WRENCH / 5+6mm SOCKET", "6.5mm SUBFIX TRIAL", "A 51 T WRENCH W/35 EXTENSION", "DRILL GUIDE BLOCK HII 10 HOLE", "TRIAL ANCHORAGE PLP30202", "ANCHORAGE INSTRUMENTS RACK (LEVEL 1)", "DJD II STORAGE CASE", "DRILL GUIDE BLOCK HII 5 HOLE", "SET ANCILLARY IMPLANT SUBTALAR", "3MM DBL SLEEVE 80MM TROC/ASSY", "HOFFMANN LRF TELES. 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NOSE - SHORT", "OMEGA PLUS SUPRACONDYLAR PIN GUIDE", "HII MICRO DRILL GUIDE ASSEMBLY", "HII COMPACT STORAGE CASE LID", "HOFFMANN LRF RATCHET WRENCH - HEX 10", "HOFFMANN3 TRAY FOR STANDARD COMPOMENTS", "4mm PREDRILL ASSEMBLY EXTRA SHORT", "Graft box locking screw", "REDUCTION HANDLES B & R CLAMPS", "OMEGA PLUS DRILL GUIDE 3.6mm DIA-COMPRESSION", "AXSOS ADAPTOR FOR TORQUE TESTER T20", "M/T TRIAX LNG HANDLE WRENCH YELLOW", "HOFFMANN LRF THUMBWHEEL FOR TELESCOPIC STRUTS", "ANCHORAGE PLATE GRIPPER", "HM MINI 4 SPANNER WRENCH", "HII MRI TRAY BASE", "DRILL GUIDE BLOCK MONOTUBE 4 HOLE", "TRIAL ANCHORAGE PLP30172", "ANCHORAGE INSTRUMENTS RACK COVER", "BIOCOMPRESSION WRENCH 25mm TUBE", "OBLONG DRILL GUIDE DIAMETER 2MM", "AEQ FRAC LONG SUP IMP ENS", "A 4 4MM CHUCK", "HII COMPACT MRI STORAGE CASE LID", "TRIAL ANCHORAGE PLP40280", "HOFFMANN XPRESS SPANNER WRENCH", "7MM SPANNER WRENCH", "OMEGA PLUS DRILL GUIDE 3.2mm DIA-1mm COMPRESSION", "6mm PREDRILL ASSEMBLY SHORT", "PEDIATRIC CORTICAL REAMER", "AO/JACOBS QUICK RELEASE APEX CHUCK 5mm", "INSTRUMENT TRAY LID FIXOS", "HII TRAY LOWER INSERT", "11.5mm SUBFIX TRIAL", "4mm PREDRILL ASSEMBLY LONG", "ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE", "AO/JACOBS QUICK RELEASE APEX CHUCK 6mm", "HII COMPACT STORAGE CASE BASE", "SCREW TRAY 4.5", "SPARE SET SCREW HUMERUS TS AIMING BLOCK", "TRIAL ANCHORAGE PLP10462", "HII MICRO STORAGE CASE BASE", "APEX TRAY LID", "10mm SUBFIX TRIAL", "HII MICRO 2mm PIN DRIVER", "CUTTING SCREWDRIVER 4.5", "EASY CLIP ANGLED DRILL GUIDE SIZE 15", "M/T TRIAX LNG HANDLE WRENCH BLUE", "TRIAL ANCHORAGE PLP10461", "TRIAL ANCHORAGE PLP40160", "5mm SPANNER WRENCH", "FIXOS 4 MV DEPTH GAUGE", "ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS)", "T-HANDLE PIN INSERTER", "Perc. Double Wire Guide", "REPLACEMENT COMPONENTS", "A 2 DRILL BRACE W/O CHUCK", "HOFFMANN LRF SPANNER WRENCH - 7/10 mm", "LID FOR PLATE RACK - SPECIAL PLATES", "TRIAL ANCHORAGE PLP10341", "BARREL REAMER ASSEMBLY STAND", "5mm PREDRILL ASSEMBLY EXTRA SHORT", "Graft box body", "SPARE SHAFT TEMP. PLATE HOLDER", "ANCHORAGE CP LAPIDUS TEMPLATE", "HOFFMANN XPRESS SILICON THUMBWHEEL", "OMEGA PLUS HEX POWERBIT W/TRKLE END 3.5mm", "MONOTUBE TRIAX YELLOW CASE", "4MM DBL SLVE 180MM TROC/ASSY", "HOFFMANN LRF WIRE TENS. NOSE - LONG", "HII MICRO STORAGE CASE LID" ], "establishment_type": [ "Manufacture Medical Device for Another Party (Contract Manufacturer)" ], "registration": { "registration_number": "2031049", "fei_number": "3001237463", "status_code": "1", "initial_importer_flag": "N", "reg_expiry_date_year": "2027", "name": "TMJ Solutions, LLC", "address_line_1": "6059 King Drive", "address_line_2": "", "city": "San Buenaventura", "state_code": "CA", "iso_country_code": "US", "zip_code": "93003", "postal_code": "", "us_agent": {}, "owner_operator": { "firm_name": "STRYKER CORP.", "owner_operator_number": "1811755", "official_correspondent": {}, "contact_address": { "address_1": "4100 East Milham Ave.", "address_2": "", "city": "Kalamazoo", "state_code": "MI", "state_province": "", "iso_country_code": "US", "postal_code": "49001" } } }, "pma_number": "", "k_number": "", "products": [ { "product_code": "LXH", "created_date": "2003-12-22", "owner_operator_number": "1811755", "exempt": "", "openfda": { "device_name": "Orthopedic Manual Surgical Instrument", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4540", "device_class": "1" } } ] } ] }