BIOLOX ALUMINA CERAMIC FEMORAL HEAD

BIOLOX ALUMINA CERAMIC FEMORAL HEAD is an FDA 510(k)-cleared medical device (K981847) manufactured by Smith & Nephew, 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 July 16, 1998. Regulation: 8.