Dynex Ring Fixation System, Diametrix Ring Fixation System

Dynex Ring Fixation System, Diametrix Ring Fixation System is an FDA 510(k)-cleared medical device (K202054) manufactured by Vilex, 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 August 23, 2020. Regulation: 8.