
Biomet Manufacturing, Inc.
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METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS is an FDA 510(k)-cleared medical device (K113271) manufactured by Biomet Manufacturing, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on May 17, 2012. Regulation: 8.