CD HORIZON™ Fenestrated Screw Set

CD HORIZON™ Fenestrated Screw Set is an FDA 510(k)-cleared medical device (K170347) manufactured by Medtronic Sofamor Danek USA. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 3, 2017. Regulation: 8.