KYPHON XPEDE Bone Cement

Cement, Bone, Vertebroplasty

MEDTRONIC

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

Pre-market Notification Details

Device IDK151227
510k NumberK151227
Device Name:KYPHON XPEDE Bone Cement
ClassificationCement, Bone, Vertebroplasty
Applicant MEDTRONIC 1800 PYRAMID PLACE Memphis,  TN  38132
ContactKathy L Remsen
CorrespondentKathy L Remsen
MEDTRONIC 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-07
Decision Date2015-11-16
Summary:summary

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