EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert is an FDA 510(k)-cleared medical device (K230169) manufactured by Encore Medical, L.P Dba Enovis. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 5, 2023. Regulation: 8.