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DePuy Orthopaedics, Inc.
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PFC SIGMA LUGGED TIBIAL TRAY is an FDA 510(k)-cleared medical device (K003026) manufactured by DePuy Orthopaedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 18, 2001. Regulation: 8.