STRYKER TRAUMA GMBH

FDA Device Registration & Listing · SCHOENKIRCHEN Schleswig-Holstein, DE · Registration 9610622

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
9610622
FEI Number
3002807231
Entity Name
STRYKER TRAUMA GMBH
City/State/Country
SCHOENKIRCHEN Schleswig-Holstein, DE
Establishment Address
PROF. KUENTSCHER STR. 1-5, SCHOENKIRCHEN Schleswig-Holstein D-24232, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
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
N/A
PMA Number
N/A

All Registered 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 Extraction 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 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 Recon Nail System T2 FLEXIBLE NAIL T2 Alpha Tibia Nailing System IMN Screws System T2 GTN T2 FEMORAL NAIL Scapel T2 FEMORAL NAIL T2 Ankle Artrodesis Nail T2 ANKLE ARTHRODESIS NAIL T2 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 T2 Nail Wrist Tray Top Layer Clip Upper Tray Dedicated Wrist Wrist Tray Reduction Insturment Clip Wrist Tray Plate Drawer Clip Wrist Tray Screw Drawer Clip T2 Nail Gamma4 IMN Screws System 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 T2 Nail Gamma4 System TIBIAL NAIL T2 Nail Krems Staple Blount Staple Epiphyseal Staple De Palma Staple Ellison Vitallium Fixation Staple System Gamma3 Nail System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1996-04-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-12-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-07-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2017-07-04
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2015-08-21
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2015-08-21
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2015-08-21
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2006-12-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-05-22
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2013-05-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2022-11-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-11-11
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1992-12-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2009-02-10
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-11-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-02-24
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-02-24
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2010-06-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-06-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-06-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-11-13
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 1977-12-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-11-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-06-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-06-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-08-14
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-08-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-08-14
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-07-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-10-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-10-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-11-13
HWJ Awl Orthopedic Class 1 888.4540 1992-12-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-03-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-03-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-06-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-07-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-06-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-06-26
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-03-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-08-27
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-08-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-02-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-02-06
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-02-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-10-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-10-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-11-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-06-06
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-02-28
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2011-01-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-02-14
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2022-02-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-06-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-06-07
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-11-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-06-19
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2012-07-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2009-05-14

Official Correspondent

No official correspondent registered.

US Agent Details

Garry Hayeck Email: garry.hayeck@stryker.com Phone: (201) 8316802

Related Public Records

Same Entity

STRYKER CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

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

Related 510(k) Records

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

Related Recall Records

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610622. Last updated year: 2026. Please use registration number 9610622 when referencing this establishment in official correspondence.
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