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: K161751
• 510k Number: K161751
• 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: Rebecca Shelburne Walker
• Correspondent: Rebecca Shelburne Walker; 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: 2016-06-24
• Decision Date: 2016-09-02
• Summary: summary