The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Reline Fenestrated Screws, High V+ Bone Cement.
| Device ID | K180498 |
| 510k Number | K180498 |
| Device Name: | NuVasive Reline Fenestrated Screws, High V+ Bone Cement |
| Classification | Bone Cement, Posterior Screw Augmentation |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Martin Yahiro |
| Correspondent | Olga Lewis NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Product Code | PML |
| Subsequent Product Code | KWP |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-26 |
| Decision Date | 2018-11-28 |
| Summary: | summary |