510(k) K070221

FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 by Encore Medical L.P. — Product Code KWA

K070221 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38". The FDA issued a decision of Substantially Equivalent on Apr 4, 2007. 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.