NORIAN SRS BONE VOID FILLER

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 Bone Void Filler.

Pre-market Notification Details

Device IDK011897
510k NumberK011897
Device Name:NORIAN SRS BONE VOID FILLER
ClassificationFiller, Bone Void, Calcium Compound
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-18
Decision Date2001-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679MXRUS20000 K011897 000

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