Luna® Ti Interbody Fusion System

Luna® Ti Interbody Fusion System is an FDA 510(k)-cleared medical device (K250773) manufactured by Spinal Elements, 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 February 3, 2026. Regulation: 8.