JWI — Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained Class II

FDA Device Classification

FDA product code JWI covers "Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained", a Class II medical device regulated under 21 CFR 888.3800. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.