The following data is part of a premarket notification filed by Nuvasive Specialized Orthopedics, Inc. with the FDA for Magec® System.
| Device ID | K201543 |
| 510k Number | K201543 |
| Device Name: | MAGEC® System |
| Classification | Growing Rod System- Magnetic Actuation |
| Applicant | NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 |
| Contact | Ivanna Lopez |
| Correspondent | Ivanna Lopez NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 |
| 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 | 2020-06-09 |
| Decision Date | 2020-07-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MAGEC 86711404 not registered Dead/Abandoned |
NUVASIVE, INC. 2015-07-31 |
![]() MAGEC 77886556 4411323 Live/Registered |
NUVASIVE, INC. 2009-12-04 |
![]() MAGEC 73408690 1270642 Dead/Cancelled |
Al Lee & Associates, Inc. 1983-01-10 |