The following data is part of a premarket notification filed by Ellipse Technologies, Inc. with the FDA for Magec Spinal Bracing And Distraction System.
| Device ID | K141278 |
| 510k Number | K141278 |
| Device Name: | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM |
| Classification | Growing Rod System- Magnetic Actuation |
| Applicant | ELLIPSE TECHNOLOGIES, INC. 13900 ALTON PARKWAY SUITE 123 Irvine, CA 92618 |
| Contact | John Mcintyre |
| Correspondent | John Mcintyre ELLIPSE TECHNOLOGIES, INC. 13900 ALTON PARKWAY SUITE 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 | 2014-05-16 |
| Decision Date | 2015-03-24 |
| Summary: | summary |