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DePuy Orthopaedics, Inc.
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ULTIMA METAL-ON-METAL ACETABULAR CUP is an FDA 510(k)-cleared medical device (K001523) manufactured by DePuy Orthopaedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on August 9, 2000. Regulation: 8.