Arzzt Distal Radius and Ulna System

Arzzt Distal Radius and Ulna System is an FDA 510(k)-cleared medical device (K182650) manufactured by Truemed Group, 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 June 9, 2019. Regulation: 8.