Medline UNITE Calcaneal Fracture Plating System

Medline UNITE Calcaneal Fracture Plating System is an FDA 510(k)-cleared medical device (K213567) manufactured by Medline Industries, LP. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 1, 2022. Regulation: 8.