NORIAN SRS FAST SET PUTTY

Filler, Bone Void, Calcium Compound

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK060406
510k NumberK060406
Device Name:NORIAN SRS FAST SET PUTTY
ClassificationFiller, Bone Void, Calcium Compound
Applicant SYNTHES (USA) 1230 WILSON DRIVE West Chester,  PA  19380
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) 1230 WILSON DRIVE West Chester,  PA  19380
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-16
Decision Date2006-03-20
Summary:summary

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