ADVANCE ULTRA-CONGRUENT TIBIAL INSERT

ADVANCE ULTRA-CONGRUENT TIBIAL INSERT is an FDA 510(k)-cleared medical device (K972770) 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 October 20, 1997. Regulation: 8.