SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices

SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices is an FDA 510(k)-cleared medical device (K190193) 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 March 3, 2019. Regulation: 8.