510(k) K063414

MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 by Encore Medical L.P. — Product Code KWA

K063414 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38". The FDA issued a decision of Substantially Equivalent on Dec 12, 2006. The device falls under product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3330. Encore Medical L.P. has 81 other 510(k) clearances on record.