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Biomet, Inc.
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BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS is an FDA 510(k)-cleared medical device (K082446) manufactured by Biomet, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on October 14, 2008. Regulation: 8.