The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Coroent Small Interlock System.
| Device ID | K192582 |
| 510k Number | K192582 |
| Device Name: | NuVasive CoRoent Small Interlock System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Jessica Leblanc |
| Correspondent | Jessica Leblanc NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-19 |
| Decision Date | 2019-11-13 |