NUVASIVE SURGICAL MESH SYSTEM

Mesh, Surgical, Polymeric

NUVASIVE, INC.

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

Pre-market Notification Details

Device IDK081377
510k NumberK081377
Device Name:NUVASIVE SURGICAL MESH SYSTEM
ClassificationMesh, Surgical, Polymeric
Applicant NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
ContactLaetitia Cousin
CorrespondentLaetitia Cousin
NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-16
Decision Date2009-01-15
Summary:summary

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