510(k) K180930

EMPOWR VVC TIBIAL INSERT by Encore Medical L.P. — Product Code JWH

K180930 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "EMPOWR VVC TIBIAL INSERT". The FDA issued a decision of Substantially Equivalent on July 9, 2018. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Encore Medical L.P. has at least 10 other 510(k) clearances on record.