GMRS PRESS FIT STEMS WITH PUREFIX HA

GMRS PRESS FIT STEMS WITH PUREFIX HA is an FDA 510(k)-cleared medical device (K031217) manufactured by Howmedica Osteonics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 22, 2003. Regulation: 8.