The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Anterior Cervical Plate Systems.
| Device ID | K212446 |
| 510k Number | K212446 |
| Device Name: | NuVasive Anterior Cervical Plate Systems |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Priscila Saraiva |
| Correspondent | Priscila Saraiva NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-05 |
| Decision Date | 2021-11-03 |