KYPHON INFLATION SYRINGE

Arthroscope

MEDTRONIC SPINE LLC

The following data is part of a premarket notification filed by Medtronic Spine Llc with the FDA for Kyphon Inflation Syringe.

Pre-market Notification Details

Device IDK103231
510k NumberK103231
Device Name:KYPHON INFLATION SYRINGE
ClassificationArthroscope
Applicant MEDTRONIC SPINE LLC 1221 Crossman Ave Sunnyvale,  CA  94089
ContactHetal Jawahar Thakker
CorrespondentHetal Jawahar Thakker
MEDTRONIC SPINE LLC 1221 Crossman Ave Sunnyvale,  CA  94089
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-01
Decision Date2011-01-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169097155 K103231 000
00643169671645 K103231 000
00643169671669 K103231 000
00643169671683 K103231 000
00643169671706 K103231 000
00643169671720 K103231 000
00643169671744 K103231 000
00643169671768 K103231 000
00643169671782 K103231 000
00643169671805 K103231 000
00643169671829 K103231 000
00643169671843 K103231 000
00643169671621 K103231 000

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