SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM

Cement, Bone, Vertebroplasty

SYNTHES (USA) LLC

The following data is part of a premarket notification filed by Synthes (usa) Llc with the FDA for Synthes Synflate Vertevral Balloon System.

Pre-market Notification Details

Device IDK130146
510k NumberK130146
Device Name:SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
ClassificationCement, Bone, Vertebroplasty
Applicant SYNTHES (USA) LLC 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactStacey Bonnell
CorrespondentStacey Bonnell
SYNTHES (USA) LLC 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-22
Decision Date2013-05-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98103804702S0 K130146 000
H98103804701S0 K130146 000
H98103804700S0 K130146 000

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