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Implex Corp.
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THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX is an FDA 510(k)-cleared medical device (K040756) manufactured by Implex Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 2004. Regulation: 8.