REUNION Sacroiliac Joint Fusion System

REUNION Sacroiliac Joint Fusion System is an FDA 510(k)-cleared medical device (K232211) manufactured by Astura Medical. 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 23, 2023. Regulation: 8.