NUVASIVE COROENT SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

NUVASIVE, INC.

The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Coroent System.

Pre-market Notification Details

Device IDK071795
510k NumberK071795
Device Name:NUVASIVE COROENT SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego,  CA  92121
ContactLaetitia Cousin
CorrespondentLaetitia Cousin
NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego,  CA  92121
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-02
Decision Date2007-12-04
Summary:summary

NIH GUDID Devices

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