AEON-C™ Stand Alone System

AEON-C™ Stand Alone System is an FDA 510(k)-cleared medical device (K223140) manufactured by Dio Medical, 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 December 19, 2022. Regulation: 8.