DART-FIRE EDGE Cannulated Screw System

DART-FIRE EDGE Cannulated Screw System is an FDA 510(k)-cleared medical device (K203228) manufactured by Wright Medical. 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 10, 2021. Regulation: 8.