The following data is part of a premarket notification filed by Spinevision Sas with the FDA for Hexanium Tlif.
| Device ID | K210359 |
| 510k Number | K210359 |
| Device Name: | Hexanium TLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SpineVision SAS 10 Rue De La Renaissance Batiment E, FR 92160 |
| Contact | Arnaud Brisard |
| Correspondent | Sevrina Ciucci Lince Consulting LLC 111 Deerwood Road, Suite 200 San Ramon, CA 94583 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2021-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03663136001715 | K210359 | 000 |
| 03663136001609 | K210359 | 000 |
| 03663136001593 | K210359 | 000 |
| 03663136001586 | K210359 | 000 |
| 03663136001579 | K210359 | 000 |
| 03663136001562 | K210359 | 000 |
| 03663136001555 | K210359 | 000 |
| 03663136001548 | K210359 | 000 |
| 03663136001531 | K210359 | 000 |
| 03663136001616 | K210359 | 000 |
| 03663136001623 | K210359 | 000 |
| 03663136001708 | K210359 | 000 |
| 03663136001692 | K210359 | 000 |
| 03663136001685 | K210359 | 000 |
| 03663136001678 | K210359 | 000 |
| 03663136001661 | K210359 | 000 |
| 03663136001654 | K210359 | 000 |
| 03663136001647 | K210359 | 000 |
| 03663136001630 | K210359 | 000 |
| 03663136001524 | K210359 | 000 |