APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD

APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD is an FDA 510(k)-cleared medical device (K101451) manufactured by Omni Life Science, 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 June 21, 2010. Regulation: 8.