The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvaisve® Reline® Cervical System.
Device ID | K191553 |
510k Number | K191553 |
Device Name: | NuVaisve® Reline® Cervical System |
Classification | Posterior Cervical Screw System |
Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
Contact | Michelle Cheung |
Correspondent | Michelle Cheung NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
Product Code | NKG |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-12 |
Decision Date | 2019-08-14 |