VBB SYSTEM

Cement, Bone, Vertebroplasty

SYNTHES

The following data is part of a premarket notification filed by Synthes with the FDA for Vbb System.

Pre-market Notification Details

Device IDK110604
510k NumberK110604
Device Name:VBB SYSTEM
ClassificationCement, Bone, Vertebroplasty
Applicant SYNTHES 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactJason Lipman
CorrespondentJason Lipman
SYNTHES 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-03
Decision Date2011-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98103804413S0 K110604 000
H98103804502S0 K110604 000
H98103804501S0 K110604 000
H98103804500S0 K110604 000

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