SYNTHES CORTICAL SCREWS

SYNTHES CORTICAL SCREWS is an FDA 510(k)-cleared medical device (K112583) manufactured by Synthes (USA) Products, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2011. Regulation: 8.