NuVasive® Growth Rod Conversion Set

Growing Rod System

NuVasive, Incorporated

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive® Growth Rod Conversion Set.

Pre-market Notification Details

• Device ID: K172979
• 510k Number: K172979
• Device Name: NuVasive® Growth Rod Conversion Set
• Classification: Growing Rod System
• 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: PGM
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-27
• Decision Date: 2017-11-06
• Summary: summary