SIRION Lateral Lumbar Interbody Fusion

SIRION Lateral Lumbar Interbody Fusion is an FDA 510(k)-cleared medical device (K202495) manufactured by Astura Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 5, 2021. Regulation: 8.