WRIGHT MEDICAL TECHNOLOGY, INC.

FDA Device Registration & Listing · Memphis, TN, US · Registration 3010667733

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010667733
FEI Number
3010667733
Entity Name
WRIGHT MEDICAL TECHNOLOGY, INC.
City/State/Country
Memphis, TN, US
Establishment Address
1023 Cherry Road, Memphis, TN 38117, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

INBONE EVOLVE DARCO Locking Bone Plate System ENDO-FUSE General Instruments Implantable K-Wire 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 SALVATION Midfoot Nail NEXFIX BOLD Screw DARCO ALLOMATRIX MDI Cartiva Pro-Toe X-Flex ORTHOLOC 3Di Small Bones Plating System Swanson ALLOMATRIX CHARLOTTE 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 BIOFOAM Bone Wedge General Instruments ICONIX All Suture Anchor System BioZip System Xcel Anchor RC System TwinLoop Anchor System Meniscal Transplant Set General Instruments Rasp MICRONAIL CHARLOTTE OSTEONICS Aequalis" PerFORM ALL TORNIER FORCEPS INSTRUMENTS General Instruments Aequalis" Fx2 Stryker Orthopaedics Screw Forceps HOLDING FORCEPS Cross-Screw System Meniscal Transplant Set Inter-Lock System TAMP General Instruments Aequalis" PerFORM INVISION Total Ankle Revision System ORTHOLOC 3Di Foot Reconstruction System ORTHOLOC 3Di Hallux System PHALINX HydroSet XT ACL Disposable Packs Portal Entry Kit General Instruments ORTHOSET EdgeLock MaxLock Extreme Mini MaxLock Extreme Osteotome General Instruments Tornier Extraction SWANSON GENERAL INSTRUMENTS OSTEONICS VARIOUS TWIST DRILLS Inter-Lock System Phoenix CinchLock BioZip System Xcel Anchor System TwinLoop FLEX ACL Workstation Universal ACL Instrumentation NanoTack Meniscal Transplant Set Cross-Screw System Mainstay Zip Anchor System TwinLoop Anchor System NanoTack Flex ICONIX All Suture Anchor System MicroFX™ DRILL BIT MANUAL DRILL BIT Tornier Drill bits (all) General Instruments 3.9mm Omega Drill 4.75mm AlphaVent and Omega Drill VariAx, Tap For Bone Screws 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill Variable Angle Fixation Knotilus+ 2.9x12.5mm Drill Knotilus+ 2.4x11.3mm Drill Knotilus+ 2.9x12.5mm Drill, Hard Bone Knotilus+ 2.9x15.5mm Drill Knotilus+ 2.4x8.9mm Drill, Hard Bone, Hip Knotilus+ 2.4X11.3mm Drill, Hard Bone Knotilus+ 2.9x15.5mm Drill, Hard Bone Knotilus+ 2.4x8.9mm Drill, Hip Knotilus+ 2.9x12.5mm Drill, Hard Bone, Hip Knotilus+ 2.9x12.5mm Drill, Hip CrossCheck Plating System 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 Infinity Total Ankle System Gaitway Implant System QUESTUS PRO-STIM Valor Hindfoot Fusion Nail System ORTHOLOC 3Di CROSSCHECK FuseForce Implant PRODENSE ORTHOLOC Bone Screws CHARLOTTE Valor Hindfoot Fusion Nail System INFINITY TOTAL ANKLE SYSTEM PRODENSE Bone Graft ADJUSTMENT FORK Fork Prophecy Infinity EZ Frame PHALINX Salvation EX FIX ORTHOLOC ORTHOLOC 3Di ORTHOSPHERE General Instruments TIE-IN DART-FIRE Infinity Total Ankle System Angled Ruler General Instruments GENERAL INSTRUMENTS PROTOE C2 2 ORTHOLOC CHARLOTTE WIRE DIRECTOR Champion Slingshot CapsulePass 45 Up Suture Passer NanoPass SlingShot STRYKER SUTURE SLIDERS Versitomic RR General Instruments PASSER ORTHOLOC 3Di Midfoot/Flatfoot System ORTHOLOC 3Di Foot Reconstruction System EVOLVE ORTHOLOC RONGEUR General Instruments SIDEKICK General Instruments DART-FIRE EDGE Cannulated Screws ALLOMATRIX SWANSON PhaLinx Hammertoe ORTHOLOC 3Di Ankle Plating System GRAVITY Pro-Toe(R) VO SWANSON CHARLOTTE MTP OSTEOSET ALLOMATRIX 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 RX-FIX SIDEKICK EZ FRAME" External Fixation System STS CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKI Twist Screw Implant Surgical Knife SIDEKICK PROSTEP MIS BUNION (TBC) PROPHECY INVISION Pre-operative Navigation Guides ORTHOLOC PRO-TOE ORTHOMET GENERAL INSTRUMENTS PUSHER HLS UNI EVOLUTION Surgical Clip/Applier GENERAL INSTRUMENTS Orthopedic Broach Mini MaxLock Extreme MaxLock General Instruments SWANSON SORBIE TOTAL ELBOW SYSTEM General Instruments CHARLOTTE SALVATION External Fixation System CSTS STRYKER TUNNELER STRYKER Y-NEEDLE 100 STRYKER Y-NEEDLE 200 STRYKER Y-NEEDLE 300 STRYKER Y-NEEDLE 400 DRILL GUIDE (ALL) Sterile Needle SI-BONE COMPRESSOR 611 - ANKLE FUSION NAIL COMPACTOR/COMPRESSION AEQUALIS RESURFACING HEAD AEQUALIS PRESS-FIT Ascend" Ascend" Flex GAITWAY CHARLOTTE MTP Bone Fusion Plate System DARCO ORTHOLOC 3DI Ankle Fusion System Mini MaxLock Extreme MFT HCS Mini MaxTorque MTP PocketLock MaxLock Extreme General Instruments ISO Pocket MaxTorque General Instruments INBONE Prophecy Incompass Surgical Planning System PROSTIM SIDEKICK DARCO BIOFOAM SALVATION External Fixation 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 General IMPACTOR Impactor, Orthopedic Manual Surgical Instrument General Instruments ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM Cartiva Inbone Total Ankle INBONE TAS ALLOMATRIX Salvation External Fixation System Pro-Toe Hammertoe Fixation System CHARLOTTE SALVATION 3Di Plating System HPI 4mm TomCat Shaver Blades 5mm HellCat Shaver Blades Aggressive Max Shaver Blade 3.5mm Dual Edge Shaver Blade 4mm Smooth Bite Shaver Blade 3.5mm Tomcat HC Shaver Blade 4mm Dual Edge Shaver Blade 3.5mm Dual Edge Shaver Blade 5.5mm ATTACHMENTS PKG., DUAL EDGE SHAVER BLADE - 5.5MM HMENTS SURGICAL INSTRUMENT MOTORS AND ACCE SMOOTH BITE SHAVER BLADE - 3.5MM SAW BLADE HLS KNEETEC PKG., AGGRESSIVE MAX SHAVER BLADE - 3.5MM PROPHECY Preoperative Navigation Alignment System EVOLVE G-FORCE PRO-DENSE MICA Screw System Hunter Tendon 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 BIOFOAM RAVINE Access System Trays CANYON Retractor Systems Trays EVEREST Spinal System Trays Triathlon System Instrument trays Navigated Spine Instruments Trays DENALI Spinal System Trays CHESAPEAKE Stabilization System Trays Cascadia Interbody System Navigation Instruments Trays Stryker Orthopaedics Instrument Trays YUKON OCT Spinal System Trays PYRENEES Cervical Plate System Trays NAPA Access System Tornier Q Pedicle Instruments Aequalis Reversed II Eikon LT Sterilization Tray CAYMAN Plate System Trays Tornier Perform Anatomic Glenoid Aequalis Fracture Aequalis Reversed Fracture CASPIAN Spinal System Trays ATP Disc Prep Pangea Platform CAPRI Corpectomy Cage System Trays INBONE Eikon LT SL Sterilization Tray MESA Spinal System Trays Restoration Modular Instrument Trays ALEUTIAN Interbody Systems Trays OZARK Cervical Plate System Trays Tornier Pyrocarbon Aluminum Lid - Universal Triathlon MSI Tray SAHARA Stabilization System Trays Sterilization Box, Lightweight Hoffmann LRF Tornier Flex Shoulder System Universal Neuro III Accessory Tray Mako Instrument Trays Stryker Orthopaedics Prosthesis Driver General Instruments driver, prosthesis PRO-TOE Charlotte Snap Off Screw INVISION Total Ankle EVOLVE WMT ULTRA-FIT MODULAR SHOULDER 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 TCP Total Compression Plating System IGNITE CHARLOTTE MUC Screw SALVATION BEAM 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. Mark’s 9 in. Retractor St. Mark’s 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 Stryker Orthopaedics Awl AWL Aequalis" Ascend" Flex Aequalis" Instrument PIP Starter Awl 3.9mm Omega and 4.75mm AlphaVent Awl 3.9mm Omega Tap General Instruments 4.75mm AlphaVent Tap Silicone MCP, Starter Awl 4.75mm AlphaVent and Omega Awl 4.75mm AlphaVent Punch Tap 4.75mm Omega Tap 5.5mm AlphaVent Tap Reusable Awl HUNTER Tendon Implants CHARLOTTE Hip Probe , 90 Hip Tissue Liberator 20 FEELER; PROBE PROBE General Instruments PRO-DENSE ORTHOLOC 3Dsi Locking Screws HV Screw System INBONE and INFINITY Total Ankle System i-Fuse Hammer Toe Systems THE SPIN SNAP-OFF SCREW Synchfix EVT PROSTEP SIDEKICK RAYHACK OSTEOSET OSTEOTOME General Instruments Prophecy Preoperative Navigation Alignment System Prophecy Surgical Planning Swanson Hammertoe Weil Design MIIG ORTHOLOC 3Di Ankle Fusion Plating System SALVATION External Fixation System Metal Hemi Implant BIOARCH EVOLVE 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 MIIG Gravity Peek Suture Anchor SWANSON CHARLOTTE ORTHOLOC, ORTHOLOC 3Di GLENOID PLANER OMNIFLEX VARIOUS STRYKER MANUA Stryker Orthopaedics Cutting Instruments General Instruments All Tornier Instruments, Cutting, Orthopeadic PLANER OSTEONICS PATELLAR CUTTER 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 General Instruments Surgical Tray INSTRUMENT TRAY LITe BIO Delivery System - Loading Tool LITe BIO Delivery System - Loading Funnel MANUAL SURGICAL INSTRUMENTS WIRE CADDY General Instruments PRECISION DOWEL BONE GRAFT SYSTEM Instruments for Coverloc Volar Plat BrainPath Manipulation Tool 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 ALLOMATRIX EVOLVE IGNITE CELLPLEX Cannulated Screw System DARCO VALOR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2021-04-26
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2021-04-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-12-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-26
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 2021-04-23
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-04-28
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2006-12-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 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 2021-04-25
KWD Prosthesis, Toe, Hemi-, Phalangeal Orthopedic Class 2 888.3730 2021-04-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-04-29
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-04-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-28
KYI Prosthesis, Wrist, Carpal Trapezium Orthopedic Class 2 888.3770 2022-01-17
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
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-26
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2003-12-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-28
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 1995-05-19
HTR Rasp General, Plastic Surgery Class 1 878.4800 1992-11-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-23
HTD Forceps General, Plastic Surgery Class 1 878.4800 1992-12-26
HXG Tamp Orthopedic Class 1 888.4540 1995-05-19
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 2021-04-23
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-05-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-05-16
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-11-04
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2016-11-04
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2006-12-28
HWM Osteotome General, Plastic Surgery Class 1 878.4800 1992-11-23
KWH Prosthesis, Toe, Constrained, Polymer Orthopedic Class 2 888.3720 2021-04-26
HSO Saw General, Plastic Surgery Class 1 878.4800 1992-11-23
HTW Bit, Drill Orthopedic Class 1 888.4540 2001-02-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-28
HTO Reamer Orthopedic Class 1 888.4540 1992-11-23
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2021-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue 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
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-28
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-28
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
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
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-04-28
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2021-04-26
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-04-28
HXE Fork Orthopedic Class 1 888.4540 2018-12-05
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
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 2021-04-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-04-28
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
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-23
KWD Prosthesis, Toe, Hemi-, Phalangeal Orthopedic Class 2 888.3730 2021-04-25
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2021-05-10
KYI Prosthesis, Wrist, Carpal Trapezium Orthopedic Class 2 888.3770 2021-04-25
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
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 1997-02-26
HXN Applier, Cerclage Orthopedic Class 1 888.4540 1978-01-12
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
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-29
HWQ Passer Orthopedic Class 1 888.4540 2006-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-26
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
HTX Rongeur Orthopedic Class 1 888.4540 1978-01-12
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-04-26
HWP Punch, Femoral Neck Orthopedic Class 1 888.4540 1978-01-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-06-10
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
KWO Prosthesis, Wrist, Carpal Scaphoid Orthopedic Class 2 888.3760 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
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-04-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-26
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
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
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-04-25
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 1995-07-11
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-04-28
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 2021-04-28
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
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2021-04-23
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 2021-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-29
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
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-26
HXO Pusher, Socket Orthopedic Class 1 888.4540 1992-11-23
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 1978-01-10
HTQ Broach Orthopedic Class 1 888.4540 2000-08-29
KWN Prosthesis, Wrist, Carpal Lunate Orthopedic Class 2 888.3750 2021-04-26
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2021-04-23
HXA Prosthesis, Tendon, Passive Orthopedic Class 2 888.3025 2021-04-26
FNS Ring Cutter General Hospital Class 1 880.6200 1978-02-02
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 2021-04-28
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2006-04-04
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2021-04-28
HWN Instrument, Compression Orthopedic Class 1 888.4540 1992-12-29
KWH Prosthesis, Toe, Constrained, Polymer Orthopedic Class 2 888.3720 2021-04-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-23
HWW Countersink Orthopedic Class 1 888.4540 1992-12-29
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2021-04-23
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2021-04-23
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
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-04-29
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
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 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
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-04-29
HXD Clamp General, Plastic Surgery Class 1 878.4800 1992-12-26
HWA Impactor Orthopedic Class 1 888.4540 1992-11-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-04-26
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-29
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2021-04-26
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2021-04-28
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
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 2021-04-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-23
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
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2004-11-15
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
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2021-04-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-04-26
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
HXA Prosthesis, Tendon, Passive Orthopedic Class 2 888.3025 2021-04-29
HWT Template Orthopedic Class 1 888.4800 2007-03-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-26
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1992-12-29
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 1992-11-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-28
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 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
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
HWX Tap, Bone Orthopedic Class 1 888.4540 2007-06-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-28
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-28
GAD Retractor General, Plastic Surgery Class 1 878.4800 2007-04-05
HWJ Awl Orthopedic Class 1 888.4540 1992-12-29
HXR Spatula, Orthopedic General, Plastic Surgery Class 1 878.4800 2021-04-28
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-04-26
HXB Probe Orthopedic Class 1 888.4540 2002-11-06
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
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-28
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 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
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-11-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-07-24
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-04-23
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
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-04-25
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 1978-01-12
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
KWH Prosthesis, Toe, Constrained, Polymer Orthopedic Class 2 888.3720 2021-04-26
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 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
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-04-28
KWD Prosthesis, Toe, Hemi-, Phalangeal Orthopedic Class 2 888.3730 2021-04-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-26
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2021-04-25
HXX Screwdriver Orthopedic Class 1 888.4540 1986-06-09
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-04-28
KWF Prosthesis, Finger, Polymer Orthopedic Class 2 888.3230 2021-05-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-23
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 1992-12-26
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2007-06-05
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2016-05-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-29
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2005-04-26
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1996-04-16
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-04-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-26
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-04-25
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
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-26
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-04-23

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
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2023 Wright Medical Technology, Inc. 2
stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
Z-0006-2023 Wright Medical Technology, Inc. 2
stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
Z-0024-2022 Exactech, Inc. 2
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
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.

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3011189525 MID SOUTH PRECISION Murfreesboro, TN, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010667733. Last updated year: 2026. Please use registration number 3010667733 when referencing this establishment in official correspondence.
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