AVAMAX VERTEBRAL BALLOON

Cement, Bone, Vertebroplasty

CAREFUSION

The following data is part of a premarket notification filed by Carefusion with the FDA for Avamax Vertebral Balloon.

Pre-market Notification Details

Device IDK103064
510k NumberK103064
Device Name:AVAMAX VERTEBRAL BALLOON
ClassificationCement, Bone, Vertebroplasty
Applicant CAREFUSION 1500 WAUKEGAN ROAD Waukegan,  IL  60085
ContactJoy Greidanus
CorrespondentJoy Greidanus
CAREFUSION 1500 WAUKEGAN ROAD Waukegan,  IL  60085
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-18
Decision Date2011-01-10
Summary:summary

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