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 IDK102397
510k NumberK102397
Device Name:KYPHON XPEDE BONE CEMENT
ClassificationCement, Bone, Vertebroplasty
Applicant Medtronic 1221 CROSSMAN AVE. Sunnyvale,  CA  94089
ContactMary Rose
CorrespondentMary Rose
Medtronic 1221 CROSSMAN AVE. Sunnyvale,  CA  94089
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-24
Decision Date2011-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994831507 K102397 000
00643169097803 K102397 000
00643169097797 K102397 000

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