DURACON(R) SMALL STABILIZER TIBIAL INSERT

DURACON(R) SMALL STABILIZER TIBIAL INSERT is an FDA 510(k)-cleared medical device (K974843) manufactured by Howmedica Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 17, 1998. Regulation: 8.