Data / Medical devices / Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained / France
FDA-registered makers of Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained in France: 5 establishments
5 establishments in France are registered with the FDA to make Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained (product code PKC). 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
- Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- Product code
- PKC
- Country
- France
Makers of Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained in France
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fx Shoulder Solutions SAS | Viriat Auvergne-Rhone-Alpes, France | Manufacturer | 2 | May 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Tornier S.A.S. | Montbonnot Saint-Martin Isere, France | Contract manufacturer, Manufacturer | 1 | March 4, 2015 | 0 | 0 | 0 | api.fda.gov |
| Marle Finishing SAS | La Talaudiere Loire, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Group | SAINT-PRIEST Auvergne-Rhone-Alpes, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westlake Plastics Europe | TOURCOING Nord, France | 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.