NuVasive Next Generation NVM5 System

Neurosurgical Nerve Locator

NUVASIVE INCORPORATED

The following data is part of a premarket notification filed by Nuvasive Incorporated with the FDA for Nuvasive Next Generation Nvm5 System.

Pre-market Notification Details

Device IDK162313
510k NumberK162313
Device Name:NuVasive Next Generation NVM5 System
ClassificationNeurosurgical Nerve Locator
Applicant NUVASIVE INCORPORATED 7475 LUSK BLVD. San Diego,  CA  92121
ContactMary Adams
CorrespondentMary Adams
NUVASIVE INCORPORATED 7475 LUSK BLVD. San Diego,  CA  92121
Product CodePDQ  
Subsequent Product CodeETN
Subsequent Product CodeGWF
Subsequent Product CodeHAW
Subsequent Product CodeIKN
Subsequent Product CodeOLO
CFR Regulation Number874.1820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-18
Decision Date2017-03-16
Summary:summary

NIH GUDID Devices

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