BIOLOX CONTOURA Ceramic Femoral Head

BIOLOX CONTOURA Ceramic Femoral Head is an FDA 510(k)-cleared medical device (K191399) manufactured by Total Joint Othopedics, 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 August 27, 2019. Regulation: 8.