MAGEC® Spinal Bracing And Distraction System

Growing Rod System- Magnetic Actuation

NuVasive Specialized Orthopedics, Inc.

The following data is part of a premarket notification filed by Nuvasive Specialized Orthopedics, Inc. with the FDA for Magec® Spinal Bracing And Distraction System.

Pre-market Notification Details

• Device ID: K160352
• 510k Number: K160352
• Device Name: MAGEC® Spinal Bracing And Distraction System
• Classification: Growing Rod System- Magnetic Actuation
• Applicant: NuVasive Specialized Orthopedics, Inc. 101 ENTERPRISE SUITE 100 Aliso Viejo, CA 92656
• Contact: Lance Justice
• Correspondent: Lance Justice; NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
• Product Code: PGN
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-08
• Decision Date: 2016-10-21
• Summary: summary