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 IDK160352
510k NumberK160352
Device Name:MAGEC® Spinal Bracing And Distraction System
ClassificationGrowing Rod System- Magnetic Actuation
Applicant NuVasive Specialized Orthopedics, Inc. 101 ENTERPRISE SUITE 100 Aliso Viejo,  CA  92656
ContactLance Justice
CorrespondentLance Justice
NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo,  CA  92656
Product CodePGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-08
Decision Date2016-10-21
Summary:summary

Trademark Results [MAGEC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAGEC
MAGEC
86711404 not registered Dead/Abandoned
NUVASIVE, INC.
2015-07-31
MAGEC
MAGEC
77886556 4411323 Live/Registered
NUVASIVE, INC.
2009-12-04
MAGEC
MAGEC
73408690 1270642 Dead/Cancelled
Al Lee & Associates, Inc.
1983-01-10

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