OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT

OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT is an FDA 510(k)-cleared medical device (K973406) 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 December 7, 1997. Regulation: 8.