Data / Medical devices / Fastener, Fixation, Biodegradable, Soft Tissue / Germany
FDA-registered makers of Fastener, Fixation, Biodegradable, Soft Tissue in Germany: 6 establishments
6 establishments in Germany are registered with the FDA to make Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Fastener, Fixation, Biodegradable, Soft Tissue
- Product code
- MAI
- Country
- Germany
Makers of Fastener, Fixation, Biodegradable, Soft Tissue in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Arthrex GmbH | Munich Bavaria, Germany | Exporter to the US, Specification developer | 22 | August 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Stryker Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 1 | November 19, 1999 | 0 | 0 | 0 | api.fda.gov |
| Fetzer Medical GMBH & Co.kg | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mediworx.one GMBH | Singen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puracon GMBH | Rosenheim Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Trauma GMBH | SCHOENKIRCHEN Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.