OMNIFIT II EPF HIP STEM SERIES

OMNIFIT II EPF HIP STEM SERIES is an FDA 510(k)-cleared medical device (K911585) 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 June 30, 1991. Regulation: 8.