Data / Medical devices / Bone Fixation Cerclage, Sublaminar / France
FDA-registered makers of Bone Fixation Cerclage, Sublaminar in France: 8 establishments
8 establishments in France are registered with the FDA to make Bone Fixation Cerclage, Sublaminar (product code OWI). 3 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Bone Fixation Cerclage, Sublaminar
- Product code
- OWI
- Country
- France
Makers of Bone Fixation Cerclage, Sublaminar in France
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Implanet | Martillac Nouvelle-Aquitaine, France | Manufacturer | 8 | August 2, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medicrea International | RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, France | Manufacturer | 3 | April 3, 2018 | 0 | 1 | 0 | api.fda.gov |
| Cousin Biotech | WERVICQ-SUD Nord, France | Contract manufacturer, Manufacturer | 1 | August 29, 2018 | 0 | 0 | 0 | api.fda.gov |
| Cefimeca | La Talaudiere Loire, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coulot Decolletage | CHATELLERAULT Vienne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lopitz Manufacturing | Gradignan Nouvelle-Aquitaine, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Simagec | ROUSSET CEDEX Bouches-du-Rhone, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Simon SAS | Bayeux Calvados, 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.