510(k) K030037

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

K030037 is an FDA 510(k) premarket notification submitted by Kinetikos Medical, Inc. for the device "UNIVERSAL TOTAL WRIST SYSTEM". The FDA issued a decision of Substantially Equivalent on February 5, 2003. 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.