Paragon 28 External Ring Fixation System

Paragon 28 External Ring Fixation System is an FDA 510(k)-cleared medical device (K212895) manufactured by Paragon 28, 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 November 7, 2021. Regulation: 8.