SafetyFix EasyOut System

SafetyFix EasyOut System is an FDA 510(k)-cleared medical device (K180753) manufactured by Safetyfix Medical Technologies, Inc.. 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 19, 2018. Regulation: 8.