NuVasive® Interfixated Interbody System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

NuVasive, Incorporated

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive® Interfixated Interbody System.

Pre-market Notification Details

• Device ID: K160051
• 510k Number: K160051
• Device Name: NuVasive® Interfixated Interbody System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121
• Contact: Michelle Cheung
• Correspondent: Michelle Cheung; NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-01-11
• Decision Date: 2016-04-20
• Summary: summary