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Biomet Manufacturing, Inc.
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REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT is an FDA 510(k)-cleared medical device (K053299) manufactured by Biomet Manufacturing, 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 January 4, 2006. Regulation: 8.