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Synthes (Usa)
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SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS is an FDA 510(k)-cleared medical device (K033868) manufactured by Synthes (Usa). This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 2004. Regulation: 8.