NuVasive® VersaTie™ System
Bone Fixation Cerclage, Sublaminar
NuVasive, Inc.
The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive® Versatie™ System.
Pre-market Notification Details
| Device ID | K173117 |
| 510k Number | K173117 |
| Device Name: | NuVasive® VersaTie™ System |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | NuVasive, Inc. 7475 Lusk Blvd San Diego, CA 92121 |
| Contact | Marysa Loustalot |
| Correspondent | Olga Lewis NuVasive, Inc. 7475 Lusk Boulevard San Diego, CA 92121 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-12-07 |
| Summary: | summary |
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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