{ "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": [ "ANCHORAGE PLATE BENDER", "8mm SUBFIX TRIAL", "BIOCOMPRESSION WRENCH 20mm TUBE", "ANCHORAGE FIXATION PIN", "AEQ TIGE FRA LG FANT", "PROTRACTOR", "TRAY", "6mm PREDRILL ASSEMBLY SHORT", "PEDIATRIC CORTICAL REAMER", "HII MRI TRAY LID", "INCLINED DRILL GUIDE SCREW EZ18", "AO/JACOBS QUICK RELEASE APEX CHUCK 5mm", "HII COMPACT MRI STORAGE CASE UPPER INSERT", "HII TRAY LOWER INSERT", "OMEGA PLUS HEAD", "4mm PREDRILL ASSEMBLY LONG", "TRIAL ANCHORAGE PLP30172", "ANCHORAGE INSTRUMENTS RACK COVER", "HII TRAY UPPER INSERT", "HII MRI TRAY LOWER INSERT", "4mm PREDRILL ASSEMBLY SHORT", "OBLONG DRILL GUIDE DIAMETER 2MM", "UNIVERSAL BENDING SLEEVE", "RING DRIVER 4.5", "TRIAL ANCHORAGE PLP11341", "LID FOR INSTRUMENT TRAY", "TIGE FRACTURE N.M", "SUBFIX INSERTION INSTRUMENT", "STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2MM", "TRIAL ANCHORAGE PLP30141", "HOFFMANN LRF THUMBWHEEL - HEX 10", "ANCHORAGE CP POLYAXIAL DRILL GUIDE", "OMEGA PLUS SUPRACONDYLAR PIN GUIDE", "TRIAL ANCHORAGE PLP30201", "HII MICRO DRILL GUIDE ASSEMBLY", "HII COMPACT STORAGE CASE LID", "MONOTUBE TRIAX YELLOW CASE", "4mm PREDRILL ASSEMBLY EXTRA SHORT", "AEQ FRAC SUPPORT DE BRAS", "AEQ FRACT GR AXE LIAISON", "M/T TRIAX LNG HANDLE WRENCH RED", "HOFFMANN XPRESS SILICON MAT", "KW BENDING IRON ICS", "HOLDING SPANNER 4.5", "HOFFMANN LRF UNIVERSAL COMPONENTS INSERT", "HII MICRO NUT DRIVER", "APEX DRILL GUIDE HANDLE", "AEQ FRACT MESUREUR AMOVIB", "CURSOR", "HOWMEDICA MIX KIT I TM 10PK", "T-HANDLE STEM HOLDER", "Graft box compression screw", "Graft box body", "AO/JACOBS QUICK RELEASE APEX CHUCK 4mm", "HOFFMANN LRF UNIVERSAL COMPONENTS TRAY", "REPLACEMENT COMPONENTS", "AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK", "RED & BLUE INTL M/T CASE", "AO HANDLE - LENGTH 135MM", "LID FOR PLATE RACK - SPECIAL PLATES", "TRIAL ANCHORAGE PLP10341", "BARREL REAMER ASSEMBLY STAND", "6mm PREDRILL ASSEMBLY EXTRA SHORT", "5mm PREDRILL ASSEMBLY EXTRA SHORT", "SILICONE MAT", "RACK FOR OPEN WEDGE PLATES (LEVEL 2)", "SCREW CADDY FOR 2 / 2.5 FIXO TRAY", "SPARE SHAFT TEMP. PLATE HOLDER", "ANCHORAGE CP LAPIDUS TEMPLATE", "DEPTH GAUGE", "OMEGA PLUS HEX POWERBIT W/TRKLE END 3.5mm", "OMEGA PLUS DRILL GUIDE 3.2mm DIA-2mm COMPRESSION", "4MM DBL SLVE 180MM TROC/ASSY", "HOFFMANN LRF WIRE TENS. 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STRUT WRENCH", "RACK FOR UTILITY/LISFRANC PLATES (LEVEL 2)", "Pangea T-Handle", "INTERMEDIATE PROSTHESIS HOLDER RIGHT", "TRIAL ANCHORAGE PLP40220", "HII MICRO STORAGE CASE LOWER INSERT", "AEQ IMPACTEUR DE PROTHESE", "AO/JACOBS QUICK RELEASE APEX CHUCK 6mm", "SCREW RACK ANCHORAGE", "6.5mm SUBFIX TRIAL", "SPARE SET SCREW HUMERUS TS AIMING BLOCK", "A 51 T WRENCH W/35 EXTENSION", "Graft sizer", "TRIAL ANCHORAGE PLP10462", "BIOCOMPRESSION WRENCH 25mm TUBE", "CUTTING SCREWDRIVER 4.5", "HOFFMANN LRF INSTRUMENTS AND IMPLANTS TRAY", "Perc. Double Wire Guide", "TRIAL ANCHORAGE PLP30171", "UNIVERSAL PIN-WIRE CASE", "TRIAL ANCHORAGE PLP11342", "HOFFMANN LRF SPANNER WRENCH - 7/10 mm", "HOFFMANN LRF SPANNER WRENCH - 5 mm", "HOFFMANN LRF WIRE BOLT WRENCH", "A 5 T-WRENCH", "DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE", "TRIAL ANCHORAGE PLP40160", "5mm SPANNER WRENCH", "FIXOS 4 MV DEPTH GAUGE", "OMEGA PLUS SUPRACONDYLAR DRILL GUIDE", "5mm PREDRILL ASSEMBLY SHORT" ], "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": "2026", "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" } } ] } ] }