Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts

Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts is an FDA 510(k)-cleared medical device (K152169) manufactured by Ortho Development Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2015. Regulation: 8.