Data / Medical devices / Thoracolumbosacral Pedicle Screw System / France
FDA-registered makers of Thoracolumbosacral Pedicle Screw System in France: 25 establishments
25 establishments in France are registered with the FDA to make Thoracolumbosacral Pedicle Screw System (product code NKB). 9 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Thoracolumbosacral Pedicle Screw System
- Product code
- NKB
- Country
- France
Makers of Thoracolumbosacral Pedicle Screw System in France
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Microtec SAS | Serres Castet Pyrenees-Atlantiques, France | Manufacturer | 8 | August 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| S.M.A.I.O | SAINT-PRIEST Auvergne-Rhone-Alpes, France | Manufacturer, Specification developer | 8 | September 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Implanet | Martillac Nouvelle-Aquitaine, France | Manufacturer | 7 | August 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medicrea International | RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, France | Manufacturer | 7 | April 8, 2022 | 0 | 2 | 0 | api.fda.gov |
| Clariance-Sas | BEAURAINS Hauts-de-France, France | Complaint file establishment, Manufacturer, Specification developer | 6 | July 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| LDR Medical | Sainte-Savine Aube, France | Specification developer | 3 | February 1, 2013 | 0 | 0 | 0 | api.fda.gov |
| Safe Orthopaedics SAS | Fleurieux-Sur-L'Arbresle Rhone, France | Manufacturer | 3 | May 3, 2013 | 0 | 0 | 0 | api.fda.gov |
| Alpes CN SAS | Reignier-Esery Haute-Savoie, France | Contract manufacturer, Manufacturer | 1 | May 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Spinevision SAS | Antony Hauts-de-Seine, France | Complaint file establishment, Manufacturer | 1 | June 7, 2012 | 0 | 0 | 0 | api.fda.gov |
| Anthogyr | SALLANCHES Haute-Savoie, France | Contract manufacturer | 0 | 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 | |
| Cousin Biotech | WERVICQ-SUD Nord, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Decomicro SAS | Naintre Nouvelle-Aquitaine, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euclide Care | Aixe Sur Vienne Haute-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 | |
| Medical Conteneur SAS | SAINT-SOUPPLETS Seine-et-Marne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oury-Guye & Fils | NOGENT Haute-Marne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precera Medical Neyron SAS | MIRIBEL CEDEX Auvergne-Rhone-Alpes, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Selenium Medical S.A.S. | La Rochelle Charente-Maritime, 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 | |
| Stryker Spine | CESTAS Nouvelle-Aquitaine, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Polyvac SAS | WAMBRECHIES Nord, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safe Medical | Fleurieux-Sur-L'Arbresle Rhone, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.