MALLORY/HEAD SMOOTH FEMORAL COMPONENT

MALLORY/HEAD SMOOTH FEMORAL COMPONENT is an FDA 510(k)-cleared medical device (K994007) manufactured by Biomet, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 3, 2000. Regulation: 8.