HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS

HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS is an FDA 510(k)-cleared medical device (K103223) 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 December 20, 2010. Regulation: 8.