CITATION TMZF HA STEM

CITATION TMZF HA STEM is an FDA 510(k)-cleared medical device (K993768) 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 20, 2000. Regulation: 8.