InFrame™ Cannulated Fixation System

InFrame™ Cannulated Fixation System is an FDA 510(k)-cleared medical device (K201430) manufactured by Exsomed Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 2020. Regulation: 8.