FDA Registration Active 🇮🇪 Ireland

STRYKER IRELAND OSTEONICS

Reg #: 9616680 · FEI: 3002459190 · Expires 2026
Products
43
Proprietary Names
795
Establishment Types
3
Classifications
43

Registration Details

Registration Name
STRYKER IRELAND OSTEONICS
Registration Number
9616680
FEI Number
3002459190
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Tullagreen Building, IDA Business & Technology Park, Carrigtwohill
City
Cork Munster
Country
IE

Regulatory Submissions

510(k) Number
K041591
PMA Number
P000013

Owner / Operator

Firm Name
STRYKER CORP.
Operator Number
1811755
Address
4100 East Milham Ave.
City
Kalamazoo
State
MI
Postal Code
49001
Country
US

Products

Device Name Product Code
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Prosthesis, Hip, Hemi-, Femoral, Metal KWL
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Wrench HXC
Cement Obturator LZN
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Screw, Fixation, Bone HWC
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Guide, Surgical, Instrument FZX
Blade, Saw, General & Plastic Surgery, Surgical GFA
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
Orthopedic Manual Surgical Instrument LXH
Template HWT
Mesh, Surgical, Acetabular, Hip, Prosthesis JDJ
Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
Wire, Surgical LRN
Cerclage, Fixation JDQ
Plate, Fixation, Bone HRS
Fixation Accessory LYT
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
Shoulder Prosthesis, Reverse Configuration PHX
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
Tape, Measuring, Rulers And Calipers FTY
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented MRA
Bit, Drill HTW
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
Retractor GAD
Tray, Surgical, Instrument FSM
Intervertebral Fusion Device With Bone Graft, Cervical ODP

Proprietary Names

Scorpio Knee System Reliance Hip Stem Accolade Hip System Restoration ADM Acetabular System General Instruments Triathlon Artisan Bone Plug; Universal Cement Restrictor LFIT V40 Femoral Heads Insignia Hip Stem Insignia Instruments Trident Acetabular System C-Taper Alumina Heads Dall Miles System Tritanium PL Cage Bone Screw Triathlon Knee System Triathlon Knee System Instrumentation Duracon Knee System Super EON Plus Femoral Stem Cement Plug 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 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 Restoration Modular Hip System, Plasma Distal Stem, Bowed 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 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 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 Osteolock Acetabular System Restoration Modular Hip System Direct Anterior Instruments Anato¿ Hip System Anato¿ Hip System Instrumentation Bixcut Reamers 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 Exeter Screws Exeter Mesh Trident X3 UHMWPE Acetabular Inserts, Restoration ADM and MDM X3 UHMWPE Acetabular Inserts, Accolade II Hip System, Triathlon Tritanium Central Femoral Cone Augments; Triathlon Femoral Distal Augments Triathlon Instrumentation Restoration Modular Total Hip System implants - proximal bodies and distal stems Exeter X3 RimFit Cup Exeter V40 Femoral Stem Universal Taper Femoral Head OmniFit Hip System PCA Acetabular System Dall Miles Cable Grip System Implants Restoration MDM Acetabular System Trident II Tritanium Acetabular Cup System and 6.5mm Low Profile Hex Screws (Solidback, Clusterhole and Multihole) Stryker Orthopaedics Instruments SecurFit AD HA Shell PCA Hip System ReUnion Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads Unitrax Modular Endo Heads Exeter Related Instrumentation UHR Bipolar Femoral Heads Exeter IM Plug Angled Ruler SecurFit Acetabular System Unix Unicompartmental Knee Restoration Modular Hip Stem System C-Taper Femoral Heads Dall Miles Cable System V40 Femoral Heads Restoration Acetabular Augments Exeter Hip System Unitrax Sleeve MDM Acetabular Liner ADM MDM Insert UHR BiPolar Exeter X3 RimFit All Poly Cup SecurFit Hip System Gap II Shell Osteolock Screws Unitrax V40 Head Anato Hip Stem Universal Cement Spacer Restoration Anatomic Acetabular Shell Tritanium Acetabular Shells Trident II Acetabular System Universal Adaptor Sleeve Kinemax Knee System Muller Acetabular Cup Monterey AL Interbody System Unitrax V40 Modular Adaptor V40 Alumina Heads System 12 Acetabular System Morse Taper Alumina Head Associated instrumentation Tritanium TL Curved Posterior Lumbar Cage Exeter Hip Stem . Distal Femoral Growing Prosthesis Kinematic Knee System PCA Knee System Modular Replacement System Precision Acetabular System Unitrax System Trident II Acetabular System (acetabular shells and related instruments) Citation Hip Stem Rejuvenate Hip Stem Biolox Delta Heads VARIOUS TWIST DRILLS Inter-Lock System Phoenix CinchLock BioZip System Xcel Anchor System TwinLoop FLEX NanoTack Cross-Screw System Mainstay Zip Anchor System NanoTack Flex ICONIX All Suture Anchor System MicroFX™ DRILL BIT MANUAL DRILL BIT Tornier Drill bits (all) 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 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 Kinemax Plus Knee System Premise Acetabular System Unitrax Osteocolock Acetabular System Centrax Vitallium Hex-Driven Bone Screw System Restoration ADM and MDM System SCR Unicompartmental Knee Avon Patella-Femoral Joint Accolade II Hip Stem ABGII Monolithic Hip Stems Scorpio Universal Dome Patella Triathlon Hinge Bumper Triathlon Tritanium Patella Triathlon Symmetric and Asymmetric Patella C-Taper Biolox Delta Ceramic Heads Restoris MCK Knee System Triathlon PKR System Series 7000 Knee System PCA Head Triathlon Tritanium Metal-Backed Patella Triathlon Single-Use Instrumentation Vitalock Acetabular System SYSTEM 12 CROSSFIRE Inserts Eccentric 10 Degree Cup Insert Crossfire Restoration Modular System Citation TMZF Hip Stems PCA Femoral Head Universal Taper Biolox Delta Femoral Head Accolade II Hip Stems ACCOLADE DISTAL SPACER Ceramic V40™ Femoral Head V40 Taper Alumina Ceramic Head Ceramic C-Taper Femoral Head UHR BIPOLAR OmniFit Crossfire Inserts Accolade Hfx Hip Stems ADM MDM Acetabular Systems Artisan Bone Plug Trident Acetabular Inserts Accolade C Hip Stems Universal C-Taper Adapter Sleeve Universal V40™ Taper Adapter Sleeve PCA Duration Insert OmniFit Acetabular Inserts OmniFit Knee System Orthinox V40 Femoral Heads Meridian Hip Stem Exeter Femoral Heads VariAx, Kirschner Wire Definition Hip Stem OmniFIt Acetabular System Trident II Dome Hole Plug 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 Tritanium Shell Kerboull Acetabular Cross Plate 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 Navigation Instruments Trays Stryker Orthopaedics Instrument Trays YUKON OCT Spinal System Trays PYRENEES Cervical Plate System Trays 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 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 PCA Femoral Heads Tritanium C Anterior Cervical Cage Triathlon PKR Triathlon Total Knee System Restoris MCK Tritanium PL Cages

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility