510(k) K040354

METAL/METAL HIP SYSTEM by Encore Medical L.P. — Product Code KWA

K040354 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "METAL/METAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on Nov 4, 2004. 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.