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 |