sagAlign Lumbar Cage System (Various PNs)

sagAlign Lumbar Cage System (Various PNs) is an FDA 510(k)-cleared medical device (K241413) 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 16, 2024. Regulation: 8.