Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set

Bone Cement, Posterior Screw Augmentation

Medtronic Sofamor Danek, USA Inc.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Usa Inc. with the FDA for Medtronic Hv-r™ Bone Cement, Kyphon™ Xpede™ Bone Cement, Cd Horizon™ Fenestrated Screw Set.

Pre-market Notification Details

Device IDK191148
510k NumberK191148
Device Name:Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set
ClassificationBone Cement, Posterior Screw Augmentation
Applicant Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactShweta Sharma
CorrespondentShweta Sharma
Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis,  TN  38132
Product CodePML  
Subsequent Product CodeNDN
Subsequent Product CodeNKB
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-30
Decision Date2019-09-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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