Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

How Is JWJ Classified?

Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained is FDA product code JWJ, Class 2, 21 CFR 888.3800.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.