CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)

CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) is an FDA 510(k)-cleared medical device (K253941) manufactured by Medtronic Sofamor Danek USA, 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 January 6, 2026. Regulation: 8.