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Encore Orthopedics, Inc.
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FMP METAL/METAL ACETABULAR INSERT is an FDA 510(k)-cleared medical device (K003250) manufactured by Encore Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on January 24, 2001. Regulation: 8.