The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Pulse System.
| Device ID | K210574 |
| 510k Number | K210574 |
| Device Name: | NuVasive Pulse System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Contact | Manthan Damani |
| Correspondent | Emily Chung NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Product Code | OLO |
| Subsequent Product Code | ETN |
| Subsequent Product Code | GWF |
| Subsequent Product Code | HAW |
| Subsequent Product Code | IKN |
| Subsequent Product Code | JAA |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | OWB |
| Subsequent Product Code | PDQ |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-26 |
| Decision Date | 2021-07-29 |