KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is an FDA 510(k)-cleared medical device (K152604) manufactured by Medtronic Sofamor Danek USA, Incorporated. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 5, 2016. Regulation: 8.