NuVasive 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 Nvm5 System.

Pre-market Notification Details

• Device ID: K143641
• 510k Number: K143641
• Device Name: NuVasive NVM5 System
• Classification: Neurosurgical Nerve Locator
• Applicant: NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121
• Contact: Jeremy Markovich
• Correspondent: Jeremy Markovich; NuVasive, Incorporated 7475 Lusk Blvd. 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: 2014-12-22
• Decision Date: 2015-03-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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