EU → US 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 I148
Class IIb73

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.

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

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