NuVasive Thoracolumbar Plates

Appliance, Fixation, Spinal Intervertebral Body

NuVasive, Incorporated

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Thoracolumbar Plates.

Pre-market Notification Details

Device IDK200956
510k NumberK200956
Device Name:NuVasive Thoracolumbar Plates
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
ContactDaniela Mahan
CorrespondentDaniela Mahan
NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-09
Decision Date2020-05-21

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