OSTEONICS SERIES 7000 AD TIBIAL TRAY

OSTEONICS SERIES 7000 AD TIBIAL TRAY is an FDA 510(k)-cleared medical device (K983657) 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 April 5, 2000. Regulation: 8.