OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES

OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES is an FDA 510(k)-cleared medical device (K951671) 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 September 5, 1995. Regulation: 8.