SIRION Lateral Lumbar Interbody System

SIRION Lateral Lumbar Interbody System is an FDA 510(k)-cleared medical device (K192006) 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 April 1, 2020. Regulation: 8.