CD Horizon Spinal System Instruments

CD Horizon Spinal System Instruments is an FDA 510(k)-cleared medical device (K203291) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 7, 2020. Regulation: 8.