NOVEL FIT AND FILL STEM

NOVEL FIT AND FILL STEM is an FDA 510(k)-cleared medical device (K122853) manufactured by Howmedica 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 January 31, 2013. Regulation: 8.