PROFEMUR GLADIATOR HA HIP STEM

PROFEMUR GLADIATOR HA HIP STEM is an FDA 510(k)-cleared medical device (K112150) manufactured by Wrightmedicaltechnologyinc. This device is classified under the Orthopedic specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on November 22, 2011. Regulation: 8.