MECTACER BIOLOX FORTE-FEMORAL HEADS

MECTACER BIOLOX FORTE-FEMORAL HEADS is an FDA 510(k)-cleared medical device (K073337) manufactured by Medacta International S.A.. 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 12, 2008. Regulation: 8.