EU → North America 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: Cervical plate, Monoaxial pedicle screws.

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

Catalogue references include S6CL535-A-S, S6M445-A-S, S6MR640-A, S6RT110M2, SCL6560-A-S, SP620-A-S.

European nomenclature codes declared: P09070302, P09070301, P09070304, P09070199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED4 674
Country of registrationFrance

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN4 674
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. NovaSpine was not found in either the U.S. or the Canadian register.

Other manufacturers in France

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