MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS

MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS is an FDA 510(k)-cleared medical device (K001548) manufactured by Howmedica Osteonics 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 6, 2000. Regulation: 8.