OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM

OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM is an FDA 510(k)-cleared medical device (K882812) 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 August 7, 1988. Regulation: 8.