Align Lumbar Interbody Fusion System

Align Lumbar Interbody Fusion System is an FDA 510(k)-cleared medical device (K221535) manufactured by Acuity Surgical Devices, 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 July 21, 2022. Regulation: 8.