The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Nuvaline Mobile App.
| Device ID | K162647 |
| 510k Number | K162647 |
| Device Name: | NuVasive NuvaLine Mobile App |
| Classification | System, Image Processing, Radiological |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
| Contact | Olga Lewis |
| Correspondent | Olga Lewis NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-22 |
| Decision Date | 2017-05-01 |
| Summary: | summary |