The following data is part of a premarket notification filed by Ellipse Technologies, Incorporated with the FDA for Magec 2 Spinal Bracing And Distraction System.
| Device ID | K150885 |
| 510k Number | K150885 |
| Device Name: | MAGEC 2 Spinal Bracing And Distraction System |
| Classification | Growing Rod System- Magnetic Actuation |
| Applicant | Ellipse Technologies, Incorporated 13900 Alton Parkway Ste 123 Irvine, CA 92618 |
| Contact | Rebecca Shelburne |
| Correspondent | Rebecca Shelburne Ellipse Technologies, Incorporated 13900 Alton Parkway Ste 123 Irvine, CA 92618 |
| Product Code | PGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-02 |
| Decision Date | 2015-05-29 |
| Summary: | summary |