
Encore Medical L.P.
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MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 is an FDA 510(k)-cleared medical device (K063414) manufactured by Encore Medical L.P.. This device is classified under the Orthopedic specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on December 11, 2006. Regulation: 8.