NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVas

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: Nuvasive Coroent Thoracolumbar System, Nuvasive Coroent Xl Interfixated System, Brigade System, Brigade Lateral System, Base Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Nuvas.

Pre-market Notification Details

Device IDK203714
510k NumberK203714
Device Name:NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVas
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
ContactJessica Leblanc
CorrespondentMartin Yahiro
NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
Product CodeMAX  
Subsequent Product CodeMQV
Subsequent Product CodeOVD
Subsequent Product CodePHM
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-21
Decision Date2021-12-23

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.