Panels › Orthopedic › Product code PGN · Class 2
Growing Rod System- Magnetic Actuation
Regulation 888.3070
0510(k)s in 12 months (9 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in PGN
| Company | 510(k)s | Recalls |
|---|---|---|
| Nuvasive Specialized Orthopedics, Inc. | 5 | 2 |
| Ellipse Technologies, Inc. | 4 | 0 |
| Globus Medical, Inc. | 0 | 1 |
| NuVasive Inc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 6, 2024 | K233593 | MAGEC Spinal Bracing and Distraction System Nuvasive Specialized Orthopedics, Incorporated | PGN |
| Jul 30, 2020 | K201543 | MAGEC® System Nuvasive Specialized Orthopedics, Inc. | PGN |
| Aug 31, 2017 | K171791 | MAGEC® System Nuvasive Specialized Orthopedics, Incorporated | PGN |
| Oct 21, 2016 | K160352 | MAGEC® Spinal Bracing and Distraction System Nuvasive Specialized Orthopedics, Inc. | PGN |
| Sep 2, 2016 | K161751 | MAGEC® Spinal Bracing and Distraction System Nuvasive Specialized Orthopedics, Inc. | PGN |
| May 29, 2015 | K150885 | MAGEC 2 Spinal Bracing and Distraction System Ellipse Technologies, Incorporated | PGN |
| Mar 24, 2015 | K141278 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM Ellipse Technologies, Inc. | PGN |
| Sep 18, 2014 | K140613 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM Ellipse Technologies, Inc. | PGN |
| Feb 27, 2014 | K140178 | ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM Ellipse Technologies, Inc. | PGN |
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