UNITY Sacroiliac Joint Fixation System

UNITY Sacroiliac Joint Fixation System is an FDA 510(k)-cleared medical device (K222448) manufactured by Dio Medical Corporation. 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 12, 2022. Regulation: 8.