KYPHON ELEMENT Inflatable Bone Tamp

Arthroscope

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Kyphon Element Inflatable Bone Tamp.

Pre-market Notification Details

Device IDK151532
510k NumberK151532
Device Name:KYPHON ELEMENT Inflatable Bone Tamp
ClassificationArthroscope
Applicant MEDTRONIC, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactPamela Edwards
CorrespondentPamela Edwards
MEDTRONIC, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-08
Decision Date2015-07-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169582217 K151532 000
00763000025823 K151532 000

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