Empowr CR Knee Tibial Insert

Empowr CR Knee Tibial Insert is an FDA 510(k)-cleared medical device (K170573) 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 May 30, 2017. Regulation: 8.