Arthrex Distal Radius System

Arthrex Distal Radius System is an FDA 510(k)-cleared medical device (K143749) manufactured by Arthrex, 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 April 2, 2015. Regulation: 8.