510(k) K152604

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set by Medtronic Sofamor Danek USA, Incorporated — Product Code PML

K152604 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek USA, Incorporated for the device "KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set". The FDA issued a decision of Substantially Equivalent on January 6, 2016. The device falls under product code PML (Bone Cement, Posterior Screw Augmentation), a Class II device regulated under 21 CFR 888.3027. Medtronic Sofamor Danek USA, Incorporated has at least 1 other 510(k) clearance on record.