NORIAN CRS FAST SET PUTTY

Methyl Methacrylate For Cranioplasty

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Norian Crs Fast Set Putty.

Pre-market Notification Details

Device IDK060443
510k NumberK060443
Device Name:NORIAN CRS FAST SET PUTTY
ClassificationMethyl Methacrylate For Cranioplasty
Applicant SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeGXP  
CFR Regulation Number882.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-21
Decision Date2006-04-13
Summary:summary

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