
Implex Corp.
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THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ is an FDA 510(k)-cleared medical device (K033384) 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 November 18, 2003. Regulation: 8.