510(k) K203557

EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing by Encore Medical L.P. — Product Code LPH

K203557 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing". The FDA issued a decision of Substantially Equivalent on February 10, 2021. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Encore Medical L.P. has at least 10 other 510(k) clearances on record.