Kyphon Xpede Bone Cement

Cement, Bone, Vertebroplasty

Medtronic Inc.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Kyphon Xpede Bone Cement.

Pre-market Notification Details

Device IDK163032
510k NumberK163032
Device Name:Kyphon Xpede Bone Cement
ClassificationCement, Bone, Vertebroplasty
Applicant Medtronic Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactPamela Edwards
CorrespondentPamela Edwards
Medtronic Inc. 1800 Pyramid Place Memphis,  TN  38132
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-31
Decision Date2017-02-27
Summary:summary

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