SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices

SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices is an FDA 510(k)-cleared medical device (K200816) manufactured by Spineex, Inc.. 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 29, 2020. Regulation: 8.