ACE 6.5 MM BONE SCREW

ACE 6.5 MM BONE SCREW is an FDA 510(k)-cleared medical device (K931652) 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 April 27, 1994. Regulation: 8.