PS OMNIFIT NORMALIZED HIP STEM SERIES

PS OMNIFIT NORMALIZED HIP STEM SERIES is an FDA 510(k)-cleared medical device (K910662) 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 May 12, 1991. Regulation: 8.