MAGEC® System
FDA 510(k) K201543 · Nuvasive Specialized Orthopedics, Inc.
510(k) numberK201543
Submission
- Device name
- MAGEC® System
- Applicant
- Nuvasive Specialized Orthopedics, Inc.
Alisa Viejo, CA, US - Received
- June 9, 2020
- Decision date
- July 30, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGN – Growing Rod System- Magnetic Actuation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.
Other 510(k)s with product code PGN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233593 | MAGEC Spinal Bracing and Distraction SystemPGN · Traditional | Nuvasive Specialized Orthopedics, Incorporated | 02/06/2024SE |
| K171791 | MAGEC® SystemPGN · Traditional | Nuvasive Specialized Orthopedics, Incorporated | 08/31/2017SE |
| K160352 | MAGEC® Spinal Bracing and Distraction SystemPGN · Traditional | Nuvasive Specialized Orthopedics, Inc. | 10/21/2016SE |
| K161751 | MAGEC® Spinal Bracing and Distraction SystemPGN · Traditional | Nuvasive Specialized Orthopedics, Inc. | 09/02/2016SE |
| K150885 | MAGEC 2 Spinal Bracing and Distraction SystemPGN · Traditional | Ellipse Technologies, Incorporated | 05/29/2015SE |
| K141278 | Magec Spinal Bracing and Distraction SystemPGN · Traditional | Ellipse Technologies, Inc. | 03/24/2015SE |
| K140613 | Magec Spinal Bracing and Distraction SystemPGN · Traditional | Ellipse Technologies, Inc. | 09/18/2014SE |
| K140178 | Ellipse Magec Spinal Bracing and Distraction SystemPGN · Traditional | Ellipse Technologies, Inc. | 02/27/2014SE |
More from Ellipse Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261651 | Precice Max System and Precice Ankle Salvage SystemHSB · Special | 06/18/2026SE |
| K233593 | MAGEC Spinal Bracing and Distraction SystemPGN · Traditional | 02/06/2024SE |
| K232267 | Precice Max SystemHSB · Traditional | 12/15/2023SE |
| K230765 | Precice Ankle Salvage SystemHSB · Traditional | 08/29/2023SE |
| K220234 | Precice Intramedullary Limb Lengthening SystemHSB · Traditional | 03/15/2023SE |
| K202348 | External Remote Controller ERC 4PHSB · Traditional | 12/22/2020SE |
| K200430 | Precice® Ankle Salvage SystemHSB · Traditional | 09/16/2020SE |
| K201567 | Precice® Bone Transport SystemHSB · Traditional | 08/10/2020SE |
| K193617 | Precice® ScrewsHSB · Traditional | 05/08/2020SE |
| K193016 | PRECICE Bone Transport SystemHSB · Traditional | 05/08/2020SE |
Questions and answers
When was MAGEC® System cleared by the FDA?
MAGEC® System (K201543) received a 510(k) decision of Substantially Equivalent on July 30, 2020, 51 days after the submission was received.
What is the product code of K201543?
The FDA product code is PGN – Growing Rod System- Magnetic Actuation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.