BIOLOX DELTA CERAMIC FEMORAL HEADS

BIOLOX DELTA CERAMIC FEMORAL HEADS is an FDA 510(k)-cleared medical device (K130899) manufactured by Zimmer GmbH. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2013. Regulation: 8.