DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS

DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS is an FDA 510(k)-cleared medical device (K915512) manufactured by Pfizer Hospital Products Group, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 17, 1992. Regulation: 8.