OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES

OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES is an FDA 510(k)-cleared medical device (K874635) 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 March 9, 1988. Regulation: 8.