ENOS Software Guided External Fixation System

ENOS Software Guided External Fixation System is an FDA 510(k)-cleared medical device (K253764) manufactured by Disior, Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 25, 2026. Regulation: 8.