DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE

DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE is an FDA 510(k)-cleared medical device (K970758) 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 May 21, 1997. Regulation: 8.