NuVasive® VersaTie® System
Bone Fixation Cerclage, Sublaminar
NuVasive, Incorporated
The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive® Versatie® System.
Pre-market Notification Details
| Device ID | K190418 |
| 510k Number | K190418 |
| Device Name: | NuVasive® VersaTie® System |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Joseph De La Rosa |
| Correspondent | Joseph De La Rosa NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-21 |
| Decision Date | 2019-03-21 |
Trademark Results [NuVasive]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NUVASIVE 76298757 2818737 Live/Registered |
NUVASIVE, INC. 2001-08-10 |
 NUVASIVE 75822001 2541247 Live/Registered |
NUVASIVE, INC. 1999-10-13 |
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