Arthrex iBalance UKA System Vitamin E Tibial Bearing

Arthrex iBalance UKA System Vitamin E Tibial Bearing is an FDA 510(k)-cleared medical device (K161060) manufactured by Arthrex, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 2016. Regulation: 8.