BIOLOX(R) DELTA CERAMIC HEADS

BIOLOX(R) DELTA CERAMIC HEADS is an FDA 510(k)-cleared medical device (K131684) 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 October 9, 2013. Regulation: 8.