OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATION

OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATION is an FDA 510(k)-cleared medical device (K920524) 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 May 14, 1992. Regulation: 8.