Data / Medical devices / Germany / Stryker Trauma GMBH

Stryker Trauma GMBH: FDA-registered device maker in SCHOENKIRCHEN Schleswig-Holstein, Germany, 2 510(k) clearances

Name: Stryker Trauma GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Stryker Trauma GMBH is registered with the FDA (registration 9610622) in SCHOENKIRCHEN Schleswig-Holstein, Germany. It lists 16 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 29, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9610622
FEI number: 3002807231
Address: Prof. Kuentscher STR. 1-5, SCHOENKIRCHEN Schleswig-Holstein, Germany, D-24232
Owner or operator: STRYKER CORP. (1811755)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: December 29, 1977
Registered through: 2027
Brand names listed: 1/1 Size silicon mat, 1/2 size silocon mat, 3.9mm Omega Tap, 3.9mm Omega and 4.75mm AlphaVent Awl, 4.75mm AlphaVent Punch Tap, 4.75mm AlphaVent Tap, 4.75mm AlphaVent and Omega Awl, 4.75mm Omega Tap and more

Devices it lists

Device	Product code	Class	Role	Source
Awl	HWJ	1	Contract manufacturer	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Contract manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Contract manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Contract manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Contract manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Contract manufacturer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Contract manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	KRO	2	Contract manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Contract manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Contract manufacturer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Contract manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Contract manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 29, 2026	K261481	Pangea Femur Reconstruction System	HSB	Substantially Equivalent	Stryker GmbH	accessdata.fda.gov
February 3, 2026	K253640	T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System	HSB	Substantially Equivalent	Stryker GmbH	accessdata.fda.gov

Compare with other makers

Updated June 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.