510(k) K080426

MAESTRO WRIST FRACTURE IMPLANT by Biomet Manufacturing Corp — Product Code JWJ

K080426 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "MAESTRO WRIST FRACTURE IMPLANT". The FDA issued a decision of Substantially Equivalent on July 29, 2008. The device falls under product code JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.