NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF 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 Mlx-medial Lateral Expandable Lumbar Interbody System, Nuvasive Ap Expandable Xlif System.

Pre-market Notification Details

Device IDK151374
510k NumberK151374
Device Name:NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant NuVasive, Incorporated 7475 Lusk Boulevard San Diego,  CA  92121
ContactOlga Lewis
CorrespondentOlga Lewis
NuVasive, Incorporated 7475 Lusk Boulevard San Diego,  CA  92121
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-22
Decision Date2015-08-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887517210173 K151374 000

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