NuVasive MOD-EX 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 Mod-ex Xlif Interbody System.

Pre-market Notification Details

Device IDK210439
510k NumberK210439
Device Name:NuVasive MOD-EX XLIF Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
ContactManthan J. Damani
CorrespondentManthan J. Damani
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 Received2021-02-12
Decision Date2021-05-12

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