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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Microtec SASSerres Castet Pyrenees-Atlantiques, FranceManufacturer8August 10, 2021000api.fda.gov
S.M.A.I.OSAINT-PRIEST Auvergne-Rhone-Alpes, FranceManufacturer, Specification developer8September 4, 2026000api.fda.gov
ImplanetMartillac Nouvelle-Aquitaine, FranceManufacturer7August 28, 2025000api.fda.gov
Medicrea InternationalRILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, FranceManufacturer7April 8, 2022020api.fda.gov
Clariance-SasBEAURAINS Hauts-de-France, FranceComplaint file establishment, Manufacturer, Specification developer6July 24, 2024000api.fda.gov
LDR MedicalSainte-Savine Aube, FranceSpecification developer3February 1, 2013000api.fda.gov
Safe Orthopaedics SASFleurieux-Sur-L'Arbresle Rhone, FranceManufacturer3May 3, 2013000api.fda.gov
Alpes CN SASReignier-Esery Haute-Savoie, FranceContract manufacturer, Manufacturer1May 1, 2026000api.fda.gov
Spinevision SASAntony Hauts-de-Seine, FranceComplaint file establishment, Manufacturer1June 7, 2012000api.fda.gov
AnthogyrSALLANCHES Haute-Savoie, FranceContract manufacturer0000api.fda.gov
CefimecaLa Talaudiere Loire, FranceContract manufacturer0000api.fda.gov
Coulot DecolletageCHATELLERAULT Vienne, FranceContract manufacturer0000api.fda.gov
Cousin BiotechWERVICQ-SUD Nord, FranceContract manufacturer0000api.fda.gov
Decomicro SASNaintre Nouvelle-Aquitaine, FranceContract manufacturer0000api.fda.gov
Euclide CareAixe Sur Vienne Haute-Vienne, FranceContract manufacturer0000api.fda.gov
Lopitz ManufacturingGradignan Nouvelle-Aquitaine, FranceContract manufacturer0000api.fda.gov
Medical Conteneur SASSAINT-SOUPPLETS Seine-et-Marne, FranceContract manufacturer0000api.fda.gov
Oury-Guye & FilsNOGENT Haute-Marne, FranceContract manufacturer0000api.fda.gov
Precera Medical Neyron SASMIRIBEL CEDEX Auvergne-Rhone-Alpes, FranceContract manufacturer0000api.fda.gov
Selenium Medical S.A.S.La Rochelle Charente-Maritime, FranceContract manufacturer0000api.fda.gov
SimagecROUSSET CEDEX Bouches-du-Rhone, FranceContract manufacturer0000api.fda.gov
Simon SASBayeux Calvados, FranceContract manufacturer0000api.fda.gov
Stryker SpineCESTAS Nouvelle-Aquitaine, FranceContract manufacturer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer0000api.fda.gov
Safe MedicalFleurieux-Sur-L'Arbresle Rhone, FranceContract manufacturer0000api.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.