EU → North America Device Access

FX Shoulder Solutions

FR-MF-000000465 · France · Viriat

FX Shoulder Solutions is registered in the European database on medical devices as a manufacturer, with 736 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa515
Class IIb73
Class I148

Most frequent device types declared: 910-0205, STANDARD SCREW TA6V Ø4.5mm L.30mm.

Among these devices, 221 are declared sterile, 221 implantable, 502 reusable, 1 active.

Devices declared under this manufacturer

Showing 12 of 736 declared devices.

Catalogue references include 105-3610, 108-4546, 109-4528, 353-0806, 451-0002, 604-0022.

European nomenclature codes declared: L091199, P09018001, L091102, P090104010202, L091201, P090104010101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryFx Shoulder Solutions SAS (FR) · FDA 3009532798
Devices in EUDAMED736
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN736
Found in the U.S. device database603
Share81.9 %

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: United States only. FX Shoulder Solutions is registered in the United States but was not found in the Canadian register.

Other manufacturers in France

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