
Polyclinic Medical Center
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HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT is an FDA 510(k)-cleared medical device (K924935) manufactured by Polyclinic Medical Center. 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 September 1, 1993. Regulation: 8.