The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Affix Iis Spinous Process Plate System.
| Device ID | K143388 |
| 510k Number | K143388 |
| Device Name: | Affix IIS Spinous Process Plate System |
| Classification | Spinous Process Plate |
| Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Contact | Olga Lewis |
| Correspondent | Olga Lewis NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-26 |
| Decision Date | 2015-03-05 |
| Summary: | summary |