SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW

SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW is an FDA 510(k)-cleared medical device (K111230) 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 May 23, 2011. Regulation: 8.