
Zimmer GmbH
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DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS is an FDA 510(k)-cleared medical device (K053536) manufactured by Zimmer GmbH. This device is classified under the Orthopedic specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on March 15, 2006. Regulation: 8.