510(k) K070061

36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT by Hayes Medical, Inc. — Product Code LWJ

K070061 is an FDA 510(k) premarket notification submitted by Hayes Medical, Inc. for the device "36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT". The FDA issued a decision of Substantially Equivalent on January 31, 2007. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Hayes Medical, Inc. has at least 10 other 510(k) clearances on record.