The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Reline Cervical System.
| Device ID | K221388 |
| 510k Number | K221388 |
| Device Name: | NuVasive Reline Cervical System |
| Classification | Posterior Cervical Screw System |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Sali Gully |
| Correspondent | Sali Gully NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-13 |
| Decision Date | 2022-09-09 |