Data / Medical devices / France / Tornier, SAS
Tornier, SAS: FDA-registered device maker in GRENOBLE CEDEX 1 Isere, France, 1 510(k) clearance
Tornier, SAS is registered with the FDA (registration 3003902387) in GRENOBLE CEDEX 1 Isere, France. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 16, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003902387
- Address
- Parc Polytec 20 Rue Des Berges, GRENOBLE CEDEX 1 Isere, France, 38024
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 23, 2021
- Registered through
- 2027
- Brand names listed
- NEXA CARPOMETACARPAL (CMI) IMPLANT, Tornier Flex Shoulder System, Tornier Pyrocarbon Humeral Head
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Wrist, Carpal Trapezium | KYI | 2 | Contract manufacturer | accessdata.fda.gov |
| Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis | QKW | 2 | 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 |
|---|---|---|---|---|---|---|
| December 16, 2022 | DEN220012 | Tornier Pyrocarbon Humeral Head | QKW | Unknown | Tornier S.A.S. | accessdata.fda.gov |
Compare with other makers
- All makers of Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
- All makers of Prosthesis, Wrist, Carpal Trapezium
Updated December 16, 2022. 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.