Hexanium® TLIF
Intervertebral Fusion Device With Bone Graft, Lumbar
SpineVision, SAS
The following data is part of a premarket notification filed by Spinevision, Sas with the FDA for Hexanium® Tlif.
Pre-market Notification Details
| Device ID | K180437 |
| 510k Number | K180437 |
| Device Name: | Hexanium® TLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SpineVision, SAS 10 Rue De La Renaissance, Batiment E Antony, FR 92160 |
| Contact | Anaella Gallego |
| Correspondent | Donald W Guthner Orgenix LLC 111 Hill Road Douglassville, PA 19518 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-05-04 |
| Summary: | summary |
Trademark Results [Hexanium]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEXANIUM 79230101 5567878 Live/Registered |
SPINEVISION 2018-02-15 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.