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Synthes (Usa)
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SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM is an FDA 510(k)-cleared medical device (K080331) manufactured by Synthes (Usa). This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2008. Regulation: 8.