CD HORIZON Spinal System, IPC POWEREASE System

CD HORIZON Spinal System, IPC POWEREASE System is an FDA 510(k)-cleared medical device (K153463) 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 December 29, 2015. Regulation: 8.