OMNIFIT DISTAL STEM CEMENT SPACERS

OMNIFIT DISTAL STEM CEMENT SPACERS is an FDA 510(k)-cleared medical device (K872528) manufactured by Osteonics Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 28, 1987. Regulation: 8.