Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1043534

FEI Number

1043534

Entity Name

WRIGHT MEDICAL TECHNOLOGY, INC.

City/State/Country

Arlington, TN, US

Establishment Address

11576 Memphis-Arlington Rd, Arlington, TN 38002, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PROSTEP SIDEKICK Universal ACL Instrumentation General Instruments Pro-Toe(R) VO SIDEKICK PRO-DENSE LoVisc SWANSON ORTHOLOC OSTEOSET OSTEOSET Pro-Toe X-Flex Prophecy Incompass Surgical Planning System HII TRAY UPPER INSERT OBLONG DRILL GUIDE DIAMETER 2MM HOFFMANN LRF INSTRUMENTS AND IMPLANTS TRAY AEQ FRACT MESUREUR AMOVIB TRIAL ANCHORAGE PLP30171 AO/JACOBS QUICK RELEASE APEX CHUCK 4mm UNIVERSAL PIN-WIRE CASE 8mm SUBFIX TRIAL HOFFMANN LRF SPANNER WRENCH - 5 mm HOFFMANN LRF WIRE BOLT WRENCH BARREL REAMER ASSEMBLY STAND SILICONE MAT DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE Perc. Double Wire Guide AEQ IMPACTEUR DE PROTHESE SET SCREW FOR TIBIA AIMING BLOCK OMEGA+ PIN W/THREAD 2.8X230MM TRIAL ANCHORAGE PLP30202 LID FOR PLATE RACK - GENERIC BIOCOMPRESSION WRENCH 15mm TUBE SET ANCILLARY IMPLANT SUBTALAR 7mm SPANNER WRENCH Graft box body AEQ USA FANT CALO AEQ FRAC SUPPORT DE BRAS SMALL SWIVEL JOINT RACK FOR OPEN WEDGE PLATES (LEVEL 2) TRIAL ANCHORAGE PLP40220 HOFFMANN XPRESS SILICON THUMBWHEEL OMEGA PLUS HEX POWERBIT W/TRKLE END 3.5mm OMEGA PLUS DRILL GUIDE 3.2mm DIA-2mm COMPRESSION APEX TRAY LOWER INSERT MONOTUBE TRIAX YELLOW CASE INSTRUMENT TRAY BASE 4.5 SPS BENDING SLEEVE - SLOTTED STEEL TIGE FRACTURE N.M Graft box compression screw Pangea T-Handle Graft box wedge T-HANDLE STEM HOLDER HOFFMANN LRF UNIVERSAL COMPONENTS TRAY HII MICRO STORAGE CASE LID AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK HII COMPACT STORAGE CASE UPPER INSERT LID FOR PLATE RACK - SPECIAL PLATES AO/JACOBS QUICK RELEASE APEX CHUCK 3mm HII MICRO STORAGE CASE LOWER INSERT 6mm PREDRILL ASSEMBLY EXTRA SHORT 5mm PREDRILL ASSEMBLY EXTRA SHORT AEQ TIGE FRA LG FANT HOFFMANN XPRESS STORAGE CASE LID HII MICRO STORAGE CASE DRILL BIT HOLDER OMEGA PLUS DRILL GUIDE HANDLE HOFFMANN LRF UNIVERSAL COMPONENTS INSERT 6mm PREDRILL ASSEMBLY LONG RACK FOR PLP UTILITY/MTP (LEVEL 2) OMEGA PLUS TAP GUIDE 4.5mm APEX TRAY BASE INTERMEDIATE PROSTHESIS HOLDER LEFT HOWMEDICA MIX KIT I TM 10PK Graft sizer M/T TRIAX LNG HANDLE WRENCH BLUE TRIAL ANCHORAGE PLP40160 ANCHORAGE PLATE BENDER ANCHORAGE FIXATION PIN T-HANDLE PIN INSERTER HII COMPACT 5mm WRENCH/3&4mm SOCKET OMEGA PLUS SUPRACONDYLAR PIN GUIDE A 5 T-WRENCH TRIAL ANCHORAGE PLP30201 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 HOFFMANN XPRESS TORQUE WRENCH 3mm PREDRILL ASSEMBLY SHORT DRILL GUIDE LOCK II 2.5 TRIAL ANCHORAGE PLP40400 HII TRAY LID HOFFMANN XPRESS STORAGE CASE INSERT M/T TRIAX LNG HANDLE WRENCH RED TRIAL ANCHORAGE PLP11341 HOLDING SPANNER 4.5 HII TRAY BASE HII MICRO NUT DRIVER MILITARY EXTERNAL FIXATION CASE 9mm SUBFIX TRIAL DEPTH GAUGE (DISTAL RADIUS) TRIAL ANCHORAGE PLP30142 DRILL GUIDE BLOCK COMPACT PERI 4 HOLE OMEGA+ VAR ANGLE GUID REPL KIT TRIAL ANCHORAGE PLP40280 DEPTH GAUGE (HAND) APEX DRILL BRACE - 3/4/5/6mm SUBFIX INSERTION INSTRUMENT TRIAL ANCHORAGE PLP30172 HII MRI TRAY LOWER INSERT CYLINDRICAL BUSH HOLDER 4mm PREDRILL ASSEMBLY SHORT Depth Gauge (Foot/Elbow/Distal Fib) ANCHORAGE PLATE GRIPPER HM MINI 4 SPANNER WRENCH 3mm PREDRILL ASSEMBLY LONG HII MRI TRAY BASE 10mm SUBFIX TRIAL DRILL GUIDE BLOCK MONOTUBE 4 HOLE DRILL GUIDE BLOCK HII 10 HOLE OMEGA PLUS TAP GUIDE 6.5mm ANCHORAGE CP MTP TEMPLATE HII 7mm T-WRENCH / 5+6mm SOCKET DJD II STORAGE CASE DRILL GUIDE BLOCK HII 5 HOLE 3MM DBL SLEEVE 80MM TROC/ASSY HOFFMANN LRF TELES. STRUT WRENCH SCREW CADDY FOR 2 / 2.5 FIXO TRAY ANCHORAGE CP POLYAXIAL DRILL GUIDE ANCHORAGE CP LAPIDUS TEMPLATE DEPTH GAUGE 4MM DBL SLVE 180MM TROC/ASSY STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2MM STANDARD BENDING SLEEVE TRAY HOFFMANN LRF WIRE TENS. NOSE - SHORT AO/JACOBS QUICK RELEASE APEX CHUCK 5mm INSTRUMENT TRAY LID FIXOS HOFFMANN XPRESS STORAGE CASE BASE TRAY FOR MV SCREWS 4mm PREDRILL ASSEMBLY LONG ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE SMALL RULER FOR MEASUREMNET SCREW TRAY 4.5 TRIAL ANCHORAGE PLP10462 APEX TRAY LID 5mm PREDRILL ASSEMBLY LONG HII MICRO 2mm PIN DRIVER CUTTING SCREWDRIVER 4.5 EASY CLIP ANGLED DRILL GUIDE SIZE 15 UniVise Restoration ADM/MDM Instrumentation Accolade II System Instrumentation OMEGA PLUS TRIAL PLATE 150 Orthopaedic Manual Instrumentation Meniscal Transplant Set Exeter Hip System Instrumentation ACL Workstation Anato Hip System Instrumentation Biosteon Wedge Interference Screw System SCREW RACK WS + CS (2MM+3.5MM) Universal ACL Instrumentation SPIKE SCREW INSERTER FOR 4.5MM SCREWS OMEGA PLUS 145 DRILL GUIDE INSERT Overdrill for 4.5mm Screws, AO TwinLoop Anchor System LITe BIO Delivery System - Sterilization Tray and Lid Reduction Tray Insert for Jaw Clamps Reduction Tray Insert for Weber Clamps Silicon Mat, Insert for Jaw Clamps Reduction Tray Silicon Mat, Insert for Weber Clamps Silicon Mat, Generic Insert Reduction Tray generic Insert Colored Plugs Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest Stanmore Face Cutter and Alignment Tool BriteField Depth Gauge Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini Terra Nova, Ravine, Serengeti, VCR, Cricket Trocar DISPOSABLE CEMENT SCULPS Counterbore Drill Tissue Protection Sleeve 206-716 w/2 small sculps/pkg Drill Sleeve AxSOS 3 Ankle Fusion AxSOS 3 Ti Posterior TLIF INTRAMEDULLARY BRUSH STANDARD 14MM OD Screwdriver Blade, AO, T10 Guide Wire Pusher Guide Wire Ruler STRAIGHT FEMORAL CANAL BRUSH Guide Wire, Threaded Guide Wire Targeter - Crown ORTHOPEDIC MANUAL Tray - Silicon Mat Bone Plug Extractor Guide Wire Targeter - Sleeve screw depth gauge Guide Wire Targeter Intraosseous Fixation system manual surgical instruments All Tornier Orthopeadic Manual Surgical Instruments (exempt) FEMORAL CANAL BRUSH, STANDARD General Instruments Edgelock manual surgical instruments AO Quick Coupling with Elastosil Handle Solid Screwdriver with AO Fitting Drill Bit ø 2,0 x 150mm Opening Reamer CalcLock manual surgical instruments Asnis® PRO Cannulated Screw System All OrthoHelix Orthopedic Manual Surgical Instruments Tornier Extraction Mini MaxLock manual surgical instruments Cannulated Screwdriver with AO Fitting Lag Screw Sleeve MaxLock Extreme manual surgical instruments Twist-drill cannulated ø8/L300mm Large AO Coupling - Hall Fitting set screw driver Threaded Guide Wire Screw Holder precision sleeve Cannulated Drill with AO Fitting Screw Insertion Sleeve Asnis® III Cannulated Screw System Guide Wire Insertion Sleeve for Guide Wire extraction shaft Multiple Drill Guide lag screw driver Drill Bit Cannulated Screwdriver with Elastosil Handle precision pin Opening Sleeve VariAx 2, Screw Rack Locking Screws VariAx 2, Screwdriver Blade VariAx 2, Inlay Holding Sleeve VariAx, Safety Shield Double Drill Guide ø 2,0/3,5mm Elastosil T-Handle with AO Coupling Opening Guide Extractor for Screws Cannulated Drill ø 2,7/3.5mm with AO Fitting Quick Release Driver Hall Fitting VariAx, Drill Guide Percutaneous guide wire inserter Cannulated Countersink with AO Fitting Tray insert Direct Measuring Gauge Stylet VariAx 2, Clip VariAx 2 Foot, Instrument Kit Parallel Guide for ø 1,4mm/2mm Wires tray base Cannulated Tap with AO Fitting Hoffmann LRF System, Wrench VariAx 2 foot, Depth Gauge lag screw reamer VariAx 2 Compression Plating System, Plate Insert AxSOS Variax 2, Steinmann Pin VariAx 2, Pliers Bixcut, IM Reamer Hoffmann LRF System, Wire Tensioner VariAx 2, Drill Guide K-Wire T2 Alpha Femur Retrograde Nailing System, Nail Adapter SPI VariAx, Tension Sheath VariAx 2, Insert VariAx, Handle VariAx 2, Drill Bit Anatomic Express Tray Hoffmann LRF System, Insert AxSOS 3 AF System and AxSOS 3 Ti System, Plate VariAx 2 Foot, Module Lid Hoffmann LRF System, Ruler VariAx 2, Distal Radius Implant Module VariAx, Screwdriver VariAx 2, Distal Radius Container Half-Size Hoffmann LRF System, Instrument VariAx 2, Screw Rack Non-Locking Screws VariAx 2, Handle With Drill Guides Dual-sided Baseplate Centering Guide T2 Alpha Femur Retrograde Nailing System, Nail Holding Screw SPI VariAx 2 Foot, Insert Stryker Trauma Pelvic Set (Matta) VariAX 2, Lid For Sterilizing Container VariAx 2, Depth Gauge VariAx Foot, Countersink VariAx 2 Foot, Tap for 2.7mm screws Extractor Rod PRO Plating System VariAx 2 Compression Plating System, Plate Trial VariAx 2, ScrewDriver Blade Modular Humeral Head Trial Post ATP Disc Prep Express Humeral Stem Extractor VariAx 2, Tap For 2.7mm Screws VariAx 2, Reduction Instrument Insert Modular Glenoid Surface Trial T2 Alpha Femur Retrograde Nailing System, Target Device NAPA Access System VariAx, Trial VariAx 2 Foot, Labeling Clip Express Insert VariAx 2, Joystick VariAx 2 Foot, Drawer VariAx 2, Fixed Angle Drill Guide 2.3/2.7mm PeriPROTM Femur VariAx, Tension Plier VariAx 2, Aiming Block Fixation Pin VariAx 2 Foot, Screw Rack VariAx 2, Handle With 2.3mm Drill And K-Wire Guide VariAx, Drill VariAx, Screw Length Marker AxSOS 3 Cascadia Interbody System Humeral Express Tray CURSOR Broach and Inserter Handle Modular Humeral Head Trial AEQ FRACT GR AXE LIAISON JA FANTOME CALOTTE T2 Alpha Femur Retrograde Nailing System, Tissue Protection Sleeve Graft box locking screw PROTRACTOR VariAx Foot, Holding Sleeve VariAx 2, Screw Rack INTERMEDIATE PROSTHESIS HOLDER RIGHT Variable Angle Fixation VariAx 2 Foot, Module Reverse Express Tray Pangea Platform Graft box washer 5mm SPANNER WRENCH HII COMPACT STORAGE CASE BASE SCREW RACK ANCHORAGE SPARE SET SCREW HUMERUS TS AIMING BLOCK 5mm PREDRILL ASSEMBLY SHORT TRIAL ANCHORAGE PLP30141 HOFFMANN LRF THUMBWHEEL - HEX 10 HII COMPACT MRI STORAGE CASE UPPER INSERT TRIAL ANCHORAGE PLP10342 HII TRAY LOWER INSERT OMEGA PLUS HEAD AO/JACOBS QUICK RELEASE APEX CHUCK 6mm TRIAL ANCHORAGE PLP40460 OMEGA PLUS LAG SCREW ADAPTER STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2.5MM PIN CUTTER / HA PINS 6.5mm SUBFIX TRIAL A 51 T WRENCH W/35 EXTENSION ANCHORAGE INSTRUMENTS RACK COVER HII MICRO STORAGE CASE BASE BIOCOMPRESSION WRENCH 25mm TUBE APEX TRAY UPPER INSERT SCREW-HOLDING FORCEPS FIXOS HOFFMANN XPRESS SILICON MAT GUIDE FOR HALF-PINS LID FOR INSTRUMENT TRAY ANCHORAGE INSTRUMENTS RACK (LEVEL 2) APEX DRILL GUIDE HANDLE HII COMPACT MRI STORAGE CASE BASE TENSION DEVICE 16MM OMEGA PLUS DRILL GUIDE 3.6mm DIA-NEUTRAL HII COMPACT GUIDE BLOCK W/AO REPLACEMENT KNOB FOR DRILL BRACE DRILL GUIDE BLOCK COMPACT 4 HOLE RACK FOR UTILITY/LISFRANC PLATES (LEVEL 2) KW BENDING IRON ICS Plastic Tray HOFFMANN LRF WIRE TENSIONER HII MICRO STORAGE CASE UPPER INSERT 4mm DBL SLEEVE 150mm TROC/ASSY REDUCTION HANDLES B & R CLAMPS M/T TRIAX LNG HANDLE WRENCH YELLOW A 4 4MM CHUCK HII COMPACT MRI STORAGE CASE LID TRIAL ANCHORAGE PLP40340 6mm PREDRILL ASSEMBLY SHORT PEDIATRIC CORTICAL REAMER HII MRI TRAY LID INCLINED DRILL GUIDE SCREW EZ18 ANCHORAGE INSTRUMENTS RACK (LEVEL 1) 11.5mm SUBFIX TRIAL SMART TOE 1 INSTRUMENT KIT HOFFMANN LRF INSTRUMENTS AND IMPLANTS INSERT ANCHORAGE FIXED DRILL GUIDE 2.5MM AO HANDLE - LENGTH 135MM AGM 6 6MM CHUCK TRIAL ANCHORAGE PLP10461 BIOCOMPRESSION WRENCH 20mm TUBE FIXOS 4 MV DEPTH GAUGE ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS) OMEGA PLUS SUPRACONDYLAR DRILL GUIDE LID FOR PLATE RACK - COMPRESSION PLATES AXSOS ADAPTOR FOR TORQUE TESTER T8/T15 INCLINED DRILLING GUIDE + SCREW EZ20 TRIAL ANCHORAGE PLP11342 REPLACEMENT COMPONENTS A 2 DRILL BRACE W/O CHUCK RED & BLUE INTL M/T CASE HOFFMANN LRF SPANNER WRENCH - 7/10 mm TRIAL ANCHORAGE PLP10341 RING DRIVER 4.5 OMEGA PLUS DRILL GUIDE 3.6mm DIA-COMPRESSION HOFFMANN LRF THUMBWHEEL FOR TELESCOPIC STRUTS OMEGA PLUS SCREW EXTRACTION BOLT AEQ FRACT NM FANT TIG SPARE SHAFT TEMP. PLATE HOLDER SET SCREW FOR HUMERUS AIMING BLOCK PLATE BENDING IRONS HOFFMANN LRF WIRE TENS. NOSE - LONG AXSOS ADAPTOR FOR TORQUE TESTER T20 HOFFMANN XPRESS SPANNER WRENCH 7MM SPANNER WRENCH OMEGA PLUS DRILL GUIDE 3.2mm DIA-1mm COMPRESSION ANCHORAGE CP MTP PIVOTING DRILL GUIDE ANCHORAGE CP UTILITY TEMPLATE HOFFMANN LRF INFO BOARD OMEGA+ BARREL REAM ASSY SHORT ANCHORAGE FIXED DRILL GUIDE 2MM UNIVERSAL BENDING SLEEVE AEQ FRAC LONG SUP IMP ENS Surgical Clip/Applier GENERAL INSTRUMENTS Angled Ruler General Instruments OSTEONOICS Angeld Farabeuf clamp Farabeuf clamp Jaw Clamp, Overbite Counterclockwise Jungbluth Clamp, Wide Jaw Clamp, Underbite Counterclockwise, Jaw Clamp, Std, Long Counterclockwise Jaw Clamp, Curved Offs. Counterclockwise Jaw Clamp, Std Offset Counterclockwise Jaw Clamp, Std Short Counterclockwise Jungbluth Clamp, Narrow Spike Disk, Large Weber Clamp Narrow Spike Disk, Oval Jaw Clamp Std Long Weber Clamp Std Weber Clamp Assmmetrical Left Jaw Clamp Large offset Straight Jaw Clamp offset Underbite Jaw Clamp Large Offset Curved Weber Clamp Assmmetrical Right Jaw Clamp offset Overbite Weber Clamp Contoured Jaw Clamp Std Short AEQUALIS FRACTURE HLS UNI EVOLUTION CLAMP FOREFOOT SET AEQUALIS Aequalis" PerFORM Aequalis" Instrument SALTO XT AEQUALIS RESURFACING HEAD General Instruments Flex Shoulder System TORNIER - INSTRUMENT SALTO TALARIS HLS KNEETEC Aequalis" Fx2 Triathlon Monogram Instruments KTEK SELECT BLADE CLAMP, US K-TEK BASIC CLAMP, US K-TEK BASIC CLAMP, EU/UK KTEK ROUND POST CLAMP, US K-TEK SELECT BLADE CLAMP, EU Pro-Toe Hammertoe Fixation System Augment Bone Graft OSTEOSET EVOLVE ORTHOLOC CHARLOTTE RX-FIX CHARLOTTE MUC Screw PRODENSE Bone Graft EVOLVE IGNITE VALOR ANKLE FUSION NAIL SYSTEM SCREW ORTHOLOC 3Di Small Bones Plating System STRYKER COMBO PUNCH OSTEONICS BONE TAP Biosteon Wedge Interference Screw System Biosteon IntraLine System Bioabsorable Wedge Interference Screw System PEEK IntraLine Anchor System TAP General Instruments MaxTorque, DRLock Extreme AxSOS 3 AxSOS Variable Angle Fixation Pangea Platform General IMPACTOR Impactor, Orthopedic Manual Surgical Instrument General Instruments Charlotte Carolina Jones FuseForce Implant Hoffmann 3 Military External Fixator Kit Reduction Instruments Complete Kit Gravity Peek Suture Anchor INVISION Total Ankle Revision System AUGMATRIX Bending Iron BENDER General Instruments Bender PRO-DENSE INFINITY TOTAL ANKLE SYSTEM 5MM FLEXIBLE REAMER 6MM FLEXIBLE REAMER 11MM FLEXIBLE REAMER 7.5MM FLEXIBLE REAMER 4.5MM FLEXIBLE REAMER 7MM FLEXIBLE REAMER 12MM FLEXIBLE REAMER 11.5MM FLEXIBLE REAMER 8MM FLEXIBLE REAMER 6.5MM FLEXIBLE REAMER 9.5MM FLEXIBLE REAMER FLEXIBLE GUIDE PIN VERSITOMIC STERILE FLEXIBLE PIN 10MM FLEXIBLE REAMER 5.5MM FLEXIBLE REAMER 8.5MM FLEXIBLE REAMER 9MM FLEXIBLE REAMER 10.5MM FLEXIBLE REAMER AEQUALIS REVERSED BIT General Surgical Bits PHALINX PRO-STIM Sidekick EZ Frame ORTHOLOC 3Di Ankle Plating System General Instruments Xia Blocker Inserter Restoration Modular Trials Tornier Radial Head System XIA Rod Template Stryker Orthopaedics Trials K2M General Instruments Stryker Orthopaedics Templates INFINITY Vikos Allograft System Triathlon MSI Trials Synchfix EVT Salvation External Fixation System INBONE GENERAL INSTRUMENTS BIOFOAM Salvation EX FIX ENDO-FUSE DARCO ORTHOLOC 3Di Ankle Fracture System SWANSON OSTEOTOME General Instruments General Instruments TIE-IN PROSTIM Caliper General Instruments CALIPER CHARLOTTE Bone Wedge BIOFOAM ADJUSTMENT FORK Fork G-FORCE SIDEKICK PRO-DENSE Cannulated Screw System HUNTER Tendon Implants SALVATION Midfoot Nail CHARLOTTE Spacer Block SUTURE BUTTON General Instruments FlowStasis Single-Pack FlowStasis FlowStasis Suture Retention Device GENERAL INSTRUMENTS FlowStasis - 3 Pack CHARLOTTE DARCO Gravity G-Force Suture Anchor System CHILDS PORTABLE TRAC General Instruments 3105-000-741 Pivot Guardian Safety Boot Liners, Medium 3105-000-740 Pivot Guardian Safety Boot Liners, Small 3105-000-742 Pivot Guardian Safety Boot Liners, Large 3105-000-305 Pivot Guardian Direct PostFree Support KEIM SURGICAL CAST TABLE DARCO Locking Bone Plate System CHARLOTTE SET SCREWDRIVER STRYKER AUTOMATIC SCREWDRIVER OSTEONICS Biosteon Wedge Interference Screw System Bioabsorable Wedge Interference Screw System Universal ACL Instrumentation Cross-Screw System ACL Reconstruction Accessories ORTHOPEDIC SCREWDRIVER DRIVER; SCREW INSERTER CalcLock Extreme MaxLock Extreme Screwdriver MaxTorque Mini MaxTorque Intraosseous Fixation System General Instruments HexStar DRLock Extreme Mini MaxLock Mini Variable PROSTEP MIS BUNION (TBC) CSTS BIOFOAM HV Screw System ORTHOLOC 3Di Ankle Fusion Plating System TCP Total Compression Plating System EVOLVE CHARLOTTE PROPHECY INVISION Pre-operative Navigation Guides ALLOMATRIX CHARLOTTE Valor Hindfoot Fusion Nail System STS BIOFOAM INVISION Total Ankle System BIOFOAM Bone Wedge Orthopedic Broach Mini MaxLock Extreme MaxLock General Instruments MIIG SIDEKICK RAYHACK OSTEOSET T DARCO Stryker Orthopaedics Prosthesis Driver General Instruments driver, prosthesis PRO-TOE INBONE EVERLAST INFINITY EVERLAST EVOLVE MICA Screw System CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKI i-Fuse Hammer Toe Systems LOCON-T Infinity Total Ankle System VALOR Eiberg Retractor, Standard Eikon LT Adapt, 90 mm, Wide Eikon LT Retractor, 135 mm, Narrow Invuity Breisky 170mm Eikon LT Retractor, A-N, 35 mm & 50 mm Eikon LT Fixed Frame Retractor, 90mm Wide Eval Eikon LT Retractor, 40 mm, Narrow Invuity St. Marks 11 in Retractor Glenoid Retractor Eikon LT Retractor, 135 mm, Sweetheart Eikon LT Retractor, 90 mm, Narrow Eikon LT Retractor, 50 mm Eikon LT Fixed Frame Retractor, 135mm Wide Eval Eikon LT Retractor, 135 mm, Wide Eikon LT Retractor, 90 mm Eikon LT Adapt Smoke Evacuation 135mm, Teeth Retractor Eikon LT Retractor, Rich, 60mm x 45mm Eikon LT Retractor, 90 mm, Wide Eikon LT Adapt Smoke Evacuation 135mm, Wide Retractor Eiberg Retractor, Standard, Long Eikon LT Adapt, 135 mm, Wide, Teeth Reusable Slat for Eikon LT Adapt Smoke Evacuation 175mm Retractor, 10 Pack Reusable Slat for Eikon LT Adapt Smoke Evacuation 135 mm Retractor, 10 Pack Eikon LT Adapt Smoke Evacuation 135mm Retractor Eikon LT Adapt Smoke Evacuation 90mm Retractor Eikon LT Adapt Smoke Evacuation 175mm, Wide Retractor Eikon LT Retractor, 40 mm, Extra Narrow Eikon LT Retractor, Rich, 40mm x 38mm Eikon LT Adapt Smoke Evacuation 90mm, Wide Retractor Eikon LT Retractor, 175 mm Eikon LT Adapt Smoke Evacuation 175mm, Wide, Teeth Retractor Eikon LT Retractor, 90 mm, Teeth Eikon LT Adapt, 175 mm Invuity A-N, 35mm & 50mm Extra Narrow Retractor Invuity Deaver 25mm Wide Retractor Eikon LT Adapt Smoke Evacuation 175mm, Teeth Retractor Invuity A-N, 35mm & 50mm Narrow Retractor Eikon LT Retractor, 90 mm, Narrow Teeth Eikon LT Adapt, 135 mm, Teeth Eikon LT Adapt Smoke Evacuation 155mm, Teeth Retractor Invuity Deaver 38mm Wide Retractor Invuity Breisky 130mm Eikon LT Adapt, 90 mm, Wide, Teeth Reusable Slat for Eikon LT Adapt Smoke Evacuation 155mm Retractor, 10 Pack Eikon LT Retractor, 90 mm, Wide, Teeth Eikon LT Fixed Frame Retractor, 135mm Eval Eikon LT Retractor, 175 mm, Teeth Eikon LT Adapt, 135 mm Eikon LT Adapt, 90 mm Eikon LT Adapt Smoke Evacuation 90mm, Teeth Retractor Eikon LT Adapt Smoke Evacuation 135mm, Wide, Teeth Retractor Eikon LT Adapt Smoke Evacuation 175mm Retractor Eikon LT Retractor, 135 mm, Teeth Eikon LT Fixed Frame Retractor, 90mm Eval Eikon LT Adapt, 135 mm, Wide Eikon LT Retractor, 135 mm, Wide, Teeth Eikon LT Adapt Smoke Evacuation 155mm, Wide, Teeth Retractor Eikon LT Retractor, 50 mm, Teeth Eikon LT Retractor, 135 mm, Narrow Teeth Eikon LT Adapt, 90 mm, Teeth Invuity St. Marks 9 in Retractor Eikon LT Adapt, 175 mm, Teeth Reusable Slat for Eikon LT Adapt Smoke Evacuation 90mm Retractor, 10 Pack Eikon LT Retractor, Rich, 80mm x 60mm Eikon LT Retractor, 135 mm Retractor Eikon LT Adapt Smoke Evacuation 155mm, Wide Retractor Eikon LT Adapt Smoke Evacuation 90mm, Wide, Teeth Retractor Eikon LT Adapt Smoke Evacuation 155mm Retractor Aequalis" Instrument Aequalis" Retractor Shoulder System HLS NOETOS AEQUALIS RESURFACING HEAD HLS UNI EVOLUTION AEQUALIS REVERSED RETRACTOR Tornier Approach Eikon LT Adapt SE 155 mm, Wide Retractor Eikon LT Adapt SE 135mm, Teeth Retractor Eikon LT FF 135mm Retractor Eikon LT FF 90mm Retractor Eikon LT Adapt SE 175 mm, Wide Retractor Eikon LT Adapt SE 90mm, Teeth Retractor 135 mm Reusable Slat, SE Retr, 10 Pack 90 mm Reusable Slat, SE Retr, 10 Pack Eikon LT Adapt SE 135mm Retractor Eikon LT Adapt SE 155 mm,Wide,Teeth Retr Eikon LT Adapt SE 175mm Retractor Eikon LT Adapt SE 155mm, Teeth Retractor 175mm Reusable Slat, SE Retr, 10 Pack Eikon LT Adapt SE 155mm Retractor St. Marks 9 in. Retractor St. Marks 11 in. Retractor Eikon LT FF 175mm Retractor Eikon LT FF 135mm, Wide Retractor Eikon LT Adapt SE 90 mm, Wide Teeth Retr Eikon LT Adapt SE 90mm Retractor Eikon LT FF Replacement Screw Invuity A-N, 35mm & 50mm Narrow Retracto 155 mm Reusable Slat, SE Retr, 10 Pack Invuity A-N, 35mm & 50mm Extra Narrow Re Eikon LT Adapt SE 175 mm,Wide,Teeth Retr Eikon LT Adapt SE 135 mm, Wide Retractor Eikon LT Adapt SE 175mm, Teeth Retractor Eikon LT FF 90mm, Wide Retractor Eikon LT Adapt SE 90 mm, Wide Retractor AEQUALIS PERFORM REVERSED RAYHACK INBONE Total Ankle System INFINITY Total Ankle System WMT ULTRA-FIT MODULAR SHOULDER SYSTEM ORTHOLOC 3DI Ankle Fusion System ORTHOLOC RAYHACK SORBIE TOTAL ELBOW SYSTEM OSTEOSET ORTHOLOC 2 Lapidus with Rotation ORTHOSPHERE SALVATION External Fixation System CHARLOTTE MTP Bone Fusion Plate System INBONE and INFINITY Total Ankle System Infinity Total Ankle System Tornier Perform® Reversed Glenoid Cannulated Glenospheres INBONE MICRONAIL Periosteal Elavator, Reverse Perisostela Elvator, Standard Periosteal Elavator, Straight TORNIER - INSTRUMENT HLS UNI EVOLUTION General Instruments 611 - ANKLE FUSION NAIL HLS NOETOS REVISION HLS KNEETEC BIOFOAM Bone Wedge EasyFuse Dynamic Compression System Charlotte Claw ORTHOLOC ORTHOLOC 3Di ORTHOLOC 3Di Foot Reconstruction System ORTHOLOC 3Di Hallux System CHARLOTTE INBONE Sterile Charlotte Staples PROPHECY INBONE GENERAL INSTRUMENTS PUSHER HLS UNI EVOLUTION SWANSON IGNITE XeroGel Nasal/Epistaxis Pack ALLOMATRIX ALLOMATRIX SIDEKICK EZ FRAME" External Fixation System General Instruments DARCO LMH G-FORCE ORTHOLOC 3Dsi Locking Screws Sterile Charlotte Bone Screws Tornier Humeral Nail PROPHECY INVISION Preoperative Navigation Alignment System EVOLVE MIIG PRODENSE Surgical Knife NEEDLE GUIDE RESECTION GUIDE OSTEONICS DRILL GUIDE ANTEVERSION GUIDE WIRE AND DRILL GUIDE DRILL SLEEVE FUNNEL Instrument Guides Drill Guide Non Sterile Tornier Extraction Cut Guide T2 Guide Wire Ball Tip VariAx 2, K-Wire VariAx 2, SpeedGuide VariAx 2 Foot, SpeedGuide Knotilus+ Offset Tip Guide Knotilus+ Crown Tip Guide Knotilus+ Crown Tip Guide, Hip VariAx Foot, K-Wire VariAx 2, Drill Guide VariAx 2, K-Wire with Olive Stop Knotilus+ Fork Tip Guide, Hip Knotilus+ Fishmouth Tip Guide Glenoid pin guide STERNUM SAW REPLACEMENT GUIDE SWANSON PROPHECY Preoperative Navigation Alignment System SALVATION External Fixation TC Plating System Stryker Orthopaedics chisel OSTEOSET SWANSON DART-FIRE EDGE Cannulated Screws SI-BONE Blueprint Patient Specific Instrumentation Tornier Perform Patient-Matched Primary Reversed Glenoid Shoulder iD Shoulder iD Primary Reversed Glenoid OSTEONICS Aequalis" PerFORM ALL TORNIER FORCEPS INSTRUMENTS General Instruments Aequalis" Fx2 Stryker Orthopaedics Screw Forceps HOLDING FORCEPS GRAVITY RASP GENERAL INSTRUMENTS EVOLVE Infinity Total Ankle System CHARLOTTE MICRONAIL CELLPLEX GAITWAY GENERAL INSTRUMENTS ACL Disposable Packs Portal Entry Kit General Instruments ORTHOSET ALLOMATRIX Cross-Screw System Meniscal Transplant Set Inter-Lock System TAMP General Instruments Aequalis" PerFORM Metal Hemi Implant Sterile Charlotte Plates PROTOE C2 2 CHARLOTTE CAROLINA General Instruments STRAIGHT MULTI-CUT SCISSORS (4BX) CURVED MULTI-CUT SCISSORS (4BX) DARCO Tornier Perform Reversed Glenoid & Tornier Perform Reversed Augmented Glenoid AEQUALIS PerFORM Reversed & AEQUALIS PerFORM+ Reversed SWANSON Tornier Radial Head System VersiTomic Low Profile Reamer5.5 mm VersiTomic Low Profile Reamer9.5 mm VersiTomic Low Profile Reamer8 mm VersiTomic Low Profile Reamer11 mm VersiTomic Low Profile Reamer4.5 mm VersiTomic Low Profile Reamer10 mm INFINITY VersiTomic Low Profile Reamer8.5 mm VersiTomic Low Profile Reamer12 mm VersiTomic Low Profile Reamer6.5 mm VersiTomic Low Profile Reamer5 mm VersiTomic Low Profile Reamer13 mm VersiTomic Low Profile Reamer7.5 mm VersiTomic Low Profile Reamer6 mm VersiTomic Low Profile Reamer7 mm VersiTomic Low Profile Reamer10.5 mm VersiTomic Low Profile Reamer9 mm EVOLVE ALLOMATRIX General Instruments MALLET Tornier Extraction Swanson Hammertoe Weil Design ORTHOLOC 3Di CROSSCHECK NexFix IMN Instruments drill Made-To-Order Tornier Simpliciti Shoulder System MaxTorque Compression Staple System Latitude EV Aequalis Perform+ CalcLock MaxLock Tornier Perform Humeral System Tornier Perform Reversed Pangea Torque Limiting Adapter Aequalis Flex Revive Tornier Extraction Tornier Humeral Nail Pangea Platform Hoffmann LRF Swanson General Instruments General Instruments Triathlon Prophecy Preoperative Navigation Alignment System Prophecy Surgical Planning PHALINX General Instruments Surgical Tray INSTRUMENT TRAY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-07-24
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2021-04-23
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-04-23
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2015-04-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-04-26
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-11-15
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2021-04-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-23
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2021-04-23
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-25
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-04-28
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2026-06-17
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2026-06-17
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2026-06-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2003-12-22
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	1978-01-10
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	Class 2	888.3770	2021-05-03
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	1997-02-26
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	1992-12-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
NOX	Filler, Bone Void, Synthetic Peptide	Unknown	Class 3	N/A	2021-04-28
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-23
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-23
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-25
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-29
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-04-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2007-06-05
HWA	Impactor	Orthopedic	Class 1	888.4540	1992-11-23
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
OJH	Orthopedic Tray	General, Plastic Surgery	Class 1	878.4800	2013-06-26
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-28
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-28
HXW	Bender	Orthopedic	Class 1	888.4540	1995-05-19
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-25
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-26
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	1995-07-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-29
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-23
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2021-04-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-04-28
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-04-28
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2021-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
HWP	Punch, Femoral Neck	Orthopedic	Class 1	888.4540	1978-01-12
HWT	Template	Orthopedic	Class 1	888.4800	2007-03-06
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-11-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-11-21
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-04-28
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-23
HXN	Applier, Cerclage	Orthopedic	Class 1	888.4540	1978-01-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	Class 2	888.3720	2021-04-26
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	1978-01-12
FNS	Ring Cutter	General Hospital	Class 1	880.6200	1978-02-02
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	Class 2	888.3770	2021-04-25
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-29
KTZ	Caliper	Orthopedic	Class 1	888.4150	1992-11-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HXE	Fork	Orthopedic	Class 1	888.4540	2018-12-05
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-04-26
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-20
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HXR	Spatula, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-05-10
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	1997-02-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-12-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2007-06-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-12-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HXX	Screwdriver	Orthopedic	Class 1	888.4540	1986-06-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2021-04-28
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-28
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-25
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-04-26
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HTQ	Broach	Orthopedic	Class 1	888.4540	2000-08-29
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-23
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-04-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-05-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	1992-11-23
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-29
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-29
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-04-23
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2007-04-05
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-04-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-04-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-29
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-04-25
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-04-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2025-07-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2021-04-23
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-25
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2021-04-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-29
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2021-04-25
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-28
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-11-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-11-23
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-26
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-04-28
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	1978-01-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-09-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-23
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-29
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-26
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-05-10
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-26
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2021-04-26
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	1992-11-23
KWF	Prosthesis, Finger, Polymer	Orthopedic	Class 2	888.3230	2021-05-03
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-25
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2018-12-28
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2018-12-28
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2021-04-23
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-23
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2021-04-25
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-25
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-04-28
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	1995-05-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2021-04-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-05-10
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2021-04-28
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-28
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2021-04-26
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-23
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-29
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-04-29
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-04-23
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1996-04-16
KWO	Prosthesis, Wrist, Carpal Scaphoid	Orthopedic	Class 2	888.3760	2021-04-26
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-29
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2021-04-29
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1994-04-29
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-25
KWN	Prosthesis, Wrist, Carpal Lunate	Orthopedic	Class 2	888.3750	2021-04-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-06-10
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2021-04-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-12-06
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-12-06
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2021-12-06
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1992-12-26
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-04-28
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1992-12-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-25
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-25
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	Class 2	888.3720	2021-04-28
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	1992-11-23
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2006-12-28
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2021-04-25
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-25
HXG	Tamp	Orthopedic	Class 1	888.4540	1995-05-19
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2021-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-05-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	1992-12-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-26
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-04-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-04-23
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	Class 2	888.3770	2021-04-23
HTO	Reamer	Orthopedic	Class 1	888.4540	1992-11-23
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2021-04-23
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-04-25
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	1992-11-23
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2021-05-03
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	Class 2	888.3720	2021-04-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-28
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2006-12-12
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	Class 2	888.3770	2022-01-17
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2021-04-23
HXC	Wrench	Orthopedic	Class 1	888.4540	1992-11-23
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2023-02-21
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2023-02-21
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2023-02-21
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2022-05-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-05-16
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-05-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

Similar Registrations

Registration Number	Establishment Name	Location
3013843055	BEIJING AK MEDICAL CO, LTD	Changping District Beijing, CN
3022777867	FIXIER S.A. DE C.V.	Doctor Mora Guanajuato, MX
3017209758	NEBULA SURGICAL PRIVATE LIMITED	Rajkot Gujarat, IN
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US
8043862	AAP IMPLANTATE AG	BERLIN, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1043534. Last updated year: 2026. Please use registration number 1043534 when referencing this establishment in official correspondence.