OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS

OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS is an FDA 510(k)-cleared medical device (K894124) 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 September 10, 1989. Regulation: 8.