CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments

CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments is an FDA 510(k)-cleared medical device (K143375) 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 February 12, 2015. Regulation: 8.