7000 SERIES MODULAR TIBIAL COMPONENTS

7000 SERIES MODULAR TIBIAL COMPONENTS is an FDA 510(k)-cleared medical device (K915192) manufactured by 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 February 13, 1992. Regulation: 8.