SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT

SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT is an FDA 510(k)-cleared medical device (K053199) 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 December 13, 2005. Regulation: 8.