PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD

PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD is an FDA 510(k)-cleared medical device (K061564) manufactured by Portland Orthopaedics Pty. , Ltd.. 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 31, 2006. Regulation: 8.