Medline UNITE® Ankle Fusion Plating System

Medline UNITE® Ankle Fusion Plating System is an FDA 510(k)-cleared medical device (K222665) manufactured by Medline Industries, 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 January 24, 2023. Regulation: 8.