OVATION 10/12 HIP STEM

OVATION 10/12 HIP STEM is an FDA 510(k)-cleared medical device (K131022) manufactured by Ortho Development 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 October 15, 2013. Regulation: 8.