KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set

Bone Cement, Posterior Screw Augmentation

Medtronic

The following data is part of a premarket notification filed by Medtronic with the FDA for Kyphon Xpede Bone Cement, Cd Horizon Fenestrated Screw Set.

Pre-market Notification Details

Device IDK171938
510k NumberK171938
Device Name:KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
ClassificationBone Cement, Posterior Screw Augmentation
Applicant Medtronic 1800 Pyramid Place Memphis,  TN  38132
ContactLee Grant
CorrespondentLee Grant
Medtronic 1800 Pyramid Place Memphis,  TN  38132
Product CodePML  
Subsequent Product CodeMNI
Subsequent Product CodeNDN
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-28
Decision Date2017-10-23
Summary:summary

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