CoRoent® Ti-C System
Intervertebral Fusion Device With Bone Graft, Lumbar
NUVASIVE, INCORPORATED
The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Coroent® Ti-c System.
Pre-market Notification Details
| Device ID | K160916 |
| 510k Number | K160916 |
| Device Name: | CoRoent® Ti-C System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Michelle Cheung |
| Correspondent | Michelle Cheung NUVASIVE, INCORPORATED 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2016-06-28 |
| Summary: | summary |
Trademark Results [CoRoent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COROENT 78385533 3033031 Live/Registered |
NuVasive, Inc. 2004-03-16 |
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