The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive® Growth Rod Conversion Set.
Device ID | K172979 |
510k Number | K172979 |
Device Name: | NuVasive® Growth Rod Conversion Set |
Classification | Growing Rod System |
Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
Contact | Olga Lewis |
Correspondent | Olga Lewis NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
Product Code | PGM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-27 |
Decision Date | 2017-11-06 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NUVASIVE 76298757 2818737 Live/Registered |
NUVASIVE, INC. 2001-08-10 |
NUVASIVE 75822001 2541247 Live/Registered |
NUVASIVE, INC. 1999-10-13 |