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 |