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DePuy Orthopaedics, Inc.
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DEPUY ASPHERE M-SPEC HEAD is an FDA 510(k)-cleared medical device (K082585) manufactured by DePuy Orthopaedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on December 3, 2008. Regulation: 8.