OSTEONICS RESTORATION MONOLITHIC HIP STEM

OSTEONICS RESTORATION MONOLITHIC HIP STEM is an FDA 510(k)-cleared medical device (K951291) 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 August 8, 1995. Regulation: 8.