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PGN — Growing Rod System- Magnetic Actuation Class II

FDA Device Classification

Classification Details

Product Code
PGN
Device Class
Class II
Regulation Number
888.3070
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233593nuvasive specialized orthopedics, incorporatedMAGEC Spinal Bracing and Distraction SystemFebruary 6, 2024
K201543nuvasive specialized orthopedicsMAGEC® SystemJuly 30, 2020
K171791nuvasive specialized orthopedics, incorporatedMAGEC® SystemAugust 31, 2017
K160352nuvasive specialized orthopedicsMAGEC® Spinal Bracing and Distraction SystemOctober 21, 2016
K161751nuvasive specialized orthopedicsMAGEC® Spinal Bracing and Distraction SystemSeptember 2, 2016
K150885ellipse technologies, incorporatedMAGEC 2 Spinal Bracing and Distraction SystemMay 29, 2015
K141278ellipse technologiesMAGEC SPINAL BRACING AND DISTRACTION SYSTEMMarch 24, 2015
K140613ellipse technologiesMAGEC SPINAL BRACING AND DISTRACTION SYSTEMSeptember 18, 2014
K140178ellipse technologiesELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEMFebruary 27, 2014