NuVasive® Reline® System

Thoracolumbosacral Pedicle Screw System

NUVASIVE, INCORPORATED

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

Pre-market Notification Details

• Device ID: K161014
• 510k Number: K161014
• Device Name: NuVasive® Reline® System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: NUVASIVE, INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121
• Contact: Thao Huynh
• Correspondent: Thao Huynh; NUVASIVE, INCORPORATED 7475 LUSK BOULEVARD San Diego, CA 92121
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: OSH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-11
• Decision Date: 2016-09-28
• Summary: summary