OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C

OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C is an FDA 510(k)-cleared medical device (K911728) 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 15, 1991. Regulation: 8.