The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Acp System.
| Device ID | K203253 |
| 510k Number | K203253 |
| Device Name: | NuVasive ACP System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| 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 | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-04 |
| Decision Date | 2020-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195377009432 | K203253 | 000 |
| 00195377009326 | K203253 | 000 |
| 00195377043757 | K203253 | 000 |
| 00195377043740 | K203253 | 000 |
| 00195377043733 | K203253 | 000 |
| 00195377043726 | K203253 | 000 |