OSTEONICS OMNIFIT FORGED HIP STEM SERIES

OSTEONICS OMNIFIT FORGED HIP STEM SERIES is an FDA 510(k)-cleared medical device (K933561) 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 March 8, 1994. Regulation: 8.