Magec Spinal Bracing and Distraction System
FDA 510(k) K141278 · Ellipse Technologies, Inc.
510(k) numberK141278
Submission
- Device name
- Magec Spinal Bracing and Distraction System
- Applicant
- Ellipse Technologies, Inc.
Irvine, CA, US - Received
- May 16, 2014
- Decision date
- March 24, 2015
- 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 |
| K201543 | MAGEC® SystemPGN · Traditional | Nuvasive Specialized Orthopedics, Inc. | 07/30/2020SE |
| 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 |
| 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 |
|---|---|---|
| K160325 | PRECICE Intramedullary Limb Lengthening SystemHSB · Traditional | 04/04/2016SE |
| K160267 | PRECICE Trauma Nail SystemHSB · Traditional | 03/31/2016SE |
| K151594 | Ellipse Supplemental Instrument TraysKCT · Abbreviated | 01/25/2016SE |
| K152370 | PRECICE Trauma Nail SystemHSB · Special | 12/22/2015SE |
| K151131 | PRECICE Intramedullary Limb Lengthening SystemHSB · Special | 06/19/2015SE |
| K150885 | MAGEC 2 Spinal Bracing and Distraction SystemPGN · Traditional | 05/29/2015SE |
| K150656 | PRECICE Intramedullary Limb Lengthening SystemHSB · Special | 04/23/2015SE |
| K142599 | PRECISE Trauma Nail SystemHSB · Traditional | 01/16/2015SE |
| K141739 | Residual Limb Lengthening SystemHSB · Traditional | 10/07/2014SE |
| K140613 | Magec Spinal Bracing and Distraction SystemPGN · Traditional | 09/18/2014SE |
Questions and answers
When was Magec Spinal Bracing and Distraction System cleared by the FDA?
Magec Spinal Bracing and Distraction System (K141278) received a 510(k) decision of Substantially Equivalent on March 24, 2015, 312 days after the submission was received.
What is the product code of K141278?
The FDA product code is PGN – Growing Rod System- Magnetic Actuation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.