MAGEC® System

Growing Rod System- Magnetic Actuation

NuVasive Specialized Orthopedics, Incorporated

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

Pre-market Notification Details

• Device ID: K171791
• 510k Number: K171791
• Device Name: MAGEC® System
• Classification: Growing Rod System- Magnetic Actuation
• Applicant: NuVasive Specialized Orthopedics, Incorporated 101 Enterprise Suite 100 Aliso Viejo, CA 92656
• Contact: Manthan J. Damani
• Correspondent: Manthan J. Damani; NuVasive Specialized Orthopedics, Incorporated 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: 2017-06-16
• Decision Date: 2017-08-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887517834041	K171791	000
00887517834034	K171791	000
00887517834027	K171791	000
00887517834010	K171791	000