EU → US Device Access

NovaSpine

FR-MF-000007304 · France · AMIENS

NovaSpine is registered in the European database on medical devices as a manufacturer, with 4 674 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb4 674

Most frequent device types declared: Monoaxial pedicle screws, Cervical plate.

Among these devices, 2 337 are declared sterile, 4 674 implantable.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED4 674
Country of registrationFrance
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Other manufacturers in France

All France manufacturers →