SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS

SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS is an FDA 510(k)-cleared medical device (K041887) 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 August 18, 2004. Regulation: 8.