FDA Registration Active 🇩🇪 Germany

STRYKER TRAUMA GMBH

Reg #: 9610622 · FEI: 3002807231 · Expires 2026
Products
17
Proprietary Names
579
Establishment Types
2
Classifications
17

Registration Details

Registration Name
STRYKER TRAUMA GMBH
Registration Number
9610622
FEI Number
3002807231
Status
Active
Expiry Year
2026
Initial Importer
No
Address
PROF. KUENTSCHER STR. 1-5
City
SCHOENKIRCHEN Schleswig-Holstein
Country
DE

Regulatory Submissions

510(k) Number
K253640

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
Guide, Surgical, Instrument FZX
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS
Pin, Fixation, Smooth HTY
Fastener, Fixation, Biodegradable, Soft Tissue MAI
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Rod, Fixation, Intramedullary And Accessories HSB
Tray, Surgical, Instrument FSM
Scalpel, One-Piece GDX
Awl HWJ
Staple, Fixation, Bone JDR
Screwdriver HXX
Orthopedic Manual Surgical Instrument LXH
Orthopedic Stereotaxic Instrument OLO
Gauge, Depth HTJ

Proprietary Names

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 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 Humeral Nail Pangea Platform Hoffmann LRF Foot Add-on Top Layer Clip 1/1 Size silicon mat Upper Tray, Generic 1/2 size silocon mat Foot Add-on Tray Plate Drawer Clip Distal Femoral Growing Prosthesis Gamma4 System T2 Nail 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 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 Tornier Flex Shoulder System Universal Neuro III Accessory Tray Mako Instrument Trays Recon Nail System T2 FLEXIBLE NAIL T2 Alpha Tibia Nailing System IMN Screws System T2 GTN T2 FEMORAL NAIL Scapel T2 Ankle Artrodesis Nail T2 ANKLE ARTHRODESIS NAIL T2 Alpha Femur Retrograde Nailing System Gamma3 System S2 FEMORAL NAIL 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 T2 ICF System Wrist Tray Top Layer Clip Upper Tray Dedicated Wrist Wrist Tray Reduction Insturment Clip Wrist Tray Plate Drawer Clip Wrist Tray Screw Drawer Clip Gamma4 T2 Nailing System T2 Alpha Humerus Nailing System T2 Alpha Femur Retrograde Nailing System, Pangea Femur Reconstruction System S2 TIBIAL NAIL T2 Recon System T2 RECON NAIL SYSTEM T2 Recon Nail System TIBIAL NAIL Krems Staple Blount Staple Epiphyseal Staple De Palma Staple Ellison Vitallium Fixation Staple System Gamma3 Nail System U-Blade Pangea PeriPRO AxSOS 3 Ti SPS Pangea Variable Angle Fixation SET SCREWDRIVER STRYKER AUTOMATIC SCREWDRIVER 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 Mini MaxTorque Intraosseous Fixation System HexStar DRLock Extreme Mini MaxLock Mini Variable FEMORAL NAIL Tibial Nail 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 SCREW RACK WS + CS (2MM+3.5MM) 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 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 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 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 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 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 TS SUPRA NAIL ADAPT for Gamma3 Fixation Pin S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL Gamma S2 Nail FLEXIBLE DEPTH GUAGE Depth Gauge DRLock Extreme, MaxLock Extreme, MaxTorque, CalcLock, Mini MaxLock Extreme Gauge, Depth OMNIFLEX

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device