The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive® Modulus-c Interbody System.
| Device ID | K172676 |
| 510k Number | K172676 |
| Device Name: | NuVasive® Modulus-C Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Contact | Marysa E. Loustalot |
| Correspondent | Cynthia Adams NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-05 |
| Decision Date | 2017-12-14 |
| 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 |