CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement

Bone Cement, Posterior Screw Augmentation

Medtronic

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

Pre-market Notification Details

Device IDK201362
510k NumberK201362
Device Name:CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement
ClassificationBone Cement, Posterior Screw Augmentation
Applicant Medtronic 1800 Pyramid Place Memphis,  TN  38132
ContactShweta Sharma
CorrespondentShweta Sharma
Medtronic 1800 Pyramid Place Memphis,  TN  38132
Product CodePML  
Subsequent Product CodeHWE
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeNDN
Subsequent Product CodeNKB
Subsequent Product CodeOLO
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-22
Decision Date2020-08-19

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