Axis Charcot Fixation System, 4.5 to 8.5mm Screw System

Axis Charcot Fixation System, 4.5 to 8.5mm Screw System is an FDA 510(k)-cleared medical device (K171018) manufactured by Extremity Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 12, 2017. Regulation: 8.