MECTACER BIOLOX(R) DELTA FEMORAL HEADS

MECTACER BIOLOX(R) DELTA FEMORAL HEADS is an FDA 510(k)-cleared medical device (K112115) manufactured by Medacta International. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 6, 2011. Regulation: 8.