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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K162313
Device Name NuVasive Next Generation NVM5 System
Applicant
NUVASIVE INCORPORATED
7475 LUSK BLVD.
SAN DIEGO,  CA  92121
Applicant Contact MARY ADAMS
Correspondent
NUVASIVE INCORPORATED
7475 LUSK BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact MARY ADAMS
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Codes
ETN   GWF   HAW   IKN   OLO  
Date Received08/18/2016
Decision Date 03/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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