Arthrex Small External Fixation System

Arthrex Small External Fixation System is an FDA 510(k)-cleared medical device (K232897) 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 October 17, 2023. Regulation: 8.