restor3d TIDAL Lumbar Interbody Fusion System

restor3d TIDAL Lumbar Interbody Fusion System is an FDA 510(k)-cleared medical device (K234087) manufactured by Restor3D. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 2024. Regulation: 8.