510(k) K021859

WRIST IMPLANT by Avanta Orthopaedics, Inc. — Product Code JWJ

K021859 is an FDA 510(k) premarket notification submitted by Avanta Orthopaedics, Inc. for the device "WRIST IMPLANT". The FDA issued a decision of Substantially Equivalent on December 2, 2002. 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. Avanta Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.