510(k) K020554

MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM by Kinetikos Medical, Inc. — Product Code JWJ

K020554 is an FDA 510(k) premarket notification submitted by Kinetikos Medical, Inc. for the device "MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM". The FDA issued a decision of Substantially Equivalent on May 3, 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. Kinetikos Medical, Inc. has at least 10 other 510(k) clearances on record.