Product code PGN

Device name: Growing Rod System- Magnetic Actuation
Medical specialty: Orthopedic
Device class: 2
Regulation number: 888.3070
Review panel: OR
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K233593	MAGEC Spinal Bracing and Distraction System	Nuvasive Specialized Orthopedics, Incorporated	2024-02-06
K201543	MAGEC® System	Nuvasive Specialized Orthopedics, Inc.	2020-07-30
K171791	MAGEC® System	Nuvasive Specialized Orthopedics, Incorporated	2017-08-31
K160352	MAGEC® Spinal Bracing and Distraction System	Nuvasive Specialized Orthopedics, Inc.	2016-10-21
K161751	MAGEC® Spinal Bracing and Distraction System	Nuvasive Specialized Orthopedics, Inc.	2016-09-02
K150885	MAGEC 2 Spinal Bracing and Distraction System	Ellipse Technologies, Incorporated	2015-05-29
K141278	MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	Ellipse Technologies, Inc.	2015-03-24
K140613	MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	Ellipse Technologies, Inc.	2014-09-18
K140178	ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	Ellipse Technologies, Inc.	2014-02-27

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00887517834027	MAGEC	Nuvasive, Inc.	2017-09-09
00887517834034	MAGEC	Nuvasive, Inc.	2017-09-09
00887517834041	MAGEC	Nuvasive, Inc.	2017-09-09
00887517834010	MAGEC	Nuvasive, Inc.	2017-09-09
00812258022600	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00812258022716	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00812258022709	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00812258022693	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00812258022686	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00812258022679	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00812258022662	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00812258022655	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00812258022648	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00812258022631	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00812258022624	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00812258022617	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00856719002244	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00856719002190	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00856719002183	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00856719002169	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00856719002152	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00856719002145	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00856719002138	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00856719002114	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2016-01-15
00812258022259	MAGEC Wand	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2015-10-15
00812258022242	MAGEC® Manual Distractor	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2015-10-15
00856719002107	External Remote Controller	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2015-10-15
00812258022723	MAGEC® Manual Distractor	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2015-10-15
00812258022839	External Remote Controller	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2015-10-15
00812258022914	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	2015-10-15

Product code PGN

Related 510(k) Records#

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