ADVANCE A-CLASS TIBIAL INSERT

ADVANCE A-CLASS TIBIAL INSERT is an FDA 510(k)-cleared medical device (K081479) manufactured by Wrightmedicaltechnologyinc. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 19, 2009. Regulation: 8.