OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES

OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES is an FDA 510(k)-cleared medical device (K944836) 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 April 9, 1995. Regulation: 8.