NuVasive Modulus XLIF Interbody System

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 Modulus Xlif Interbody System.

Pre-market Notification Details

Device IDK201692
510k NumberK201692
Device Name:NuVasive Modulus XLIF Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
ContactJessica Leblanc
CorrespondentJessica Leblanc
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 Received2020-06-22
Decision Date2020-10-29

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