NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System And Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Inte

Intervertebral Fusion Device With Bone Graft, Lumbar

NuVasive, Incorporated

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Thoracolumbar Interbody Systems: Coroent Thoracolumbar System, Coroent Xl Interfixated System, Brigade Standalone System And Brigade Hyperlordotic System, Brigade Lateral System, Base Interfixated Titanium System, Coalesce Thoracolumbar Inte.

Pre-market Notification Details

Device IDK201820
510k NumberK201820
Device Name:NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System And Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Inte
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant NuVasive, Incorporated 7475 Lusk Blvd San Diego,  CA  92121
ContactDaniela Mahan
CorrespondentDaniela Mahan
NuVasive, Incorporated 7475 Lusk Blvd San Diego,  CA  92121
Product CodeMAX  
Subsequent Product CodeOVD
Subsequent Product CodePHM
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-01
Decision Date2020-09-25

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