ACE 3.5MM CORTICAL BONE SCREW

ACE 3.5MM CORTICAL BONE SCREW is an FDA 510(k)-cleared medical device (K905048) manufactured by Ace Medical Co.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 1991. Regulation: 8.