FDA 510(k) Applications for Medical Device Product Code: PGN ()

FDA 510(k) Applications for Medical Device Product Code "PGN"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K140613	ELLIPSE TECHNOLOGIES INC.	MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	09/18/2014
K140178	ELLIPSE TECHNOLOGIES, INC.	ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	02/27/2014
K141278	ELLIPSE TECHNOLOGIES, INC.	MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	03/24/2015
K150885	Ellipse Technologies, Incorporated	MAGEC 2 Spinal Bracing and Distraction System	05/29/2015
K160352	NuVasive Specialized Orthopedics, Inc.	MAGEC« Spinal Bracing and Distraction System	10/21/2016
K161751	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	MAGEC« Spinal Bracing and Distraction System	09/02/2016
K201543	NuVasive Specialized Orthopedics, Inc.	MAGEC« System	07/30/2020
K171791	NuVasive Specialized Orthopedics, Incorporated	MAGEC« System	08/31/2017