ACE/KYLE CAPTURED HIP SCREW

ACE/KYLE CAPTURED HIP SCREW is an FDA 510(k)-cleared medical device (K813554) manufactured by Ace Orthopedic Manufacturing 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 11, 1982. Regulation: 8.