NuVasiveNVM5 System

Neurosurgical Nerve Locator

The following data is part of a premarket notification filed by Nuvasive Incorporated with the FDA for Nuvasivenvm5 System.

Device ID	K152942
510k Number	K152942
Device Name:	NuVasiveNVM5 System
Classification	Neurosurgical Nerve Locator
Applicant	NUVASIVE INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121
Contact	Olga Lewis
Correspondent	Olga Lewis NUVASIVE INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121
Product Code	PDQ
Subsequent Product Code	ETN
Subsequent Product Code	GWF
Subsequent Product Code	HAW
Subsequent Product Code	IKN
Subsequent Product Code	OLO
CFR Regulation Number	874.1820 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2015-10-05
Decision Date	2016-01-13
Summary:	summary