MAGEC® 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® System.

Pre-market Notification Details

Device IDK201543
510k NumberK201543
Device Name:MAGEC® System
ClassificationGrowing Rod System- Magnetic Actuation
Applicant NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo,  CA  92656
ContactIvanna Lopez
CorrespondentIvanna Lopez
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 Received2020-06-09
Decision Date2020-07-30

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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