EMPOWR VVC TIBIAL INSERT

EMPOWR VVC TIBIAL INSERT is an FDA 510(k)-cleared medical device (K180930) manufactured by Encore Medical L.P.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 8, 2018. Regulation: 8.