
Consensus Orthopedics, Inc.
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CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD is an FDA 510(k)-cleared medical device (K110542) manufactured by Consensus Orthopedics, 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 March 31, 2011. Regulation: 8.