CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition

CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition is an FDA 510(k)-cleared medical device (K182121) 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 November 1, 2018. Regulation: 8.