THE OMNIFIT EPF HIP JOINT FEMORAL STEM

THE OMNIFIT EPF HIP JOINT FEMORAL STEM is an FDA 510(k)-cleared medical device (K896047) 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 December 19, 1990. Regulation: 8.