The following data is part of a premarket notification filed by Spineart with the FDA for Scarlet Al-t.
| Device ID | K192993 |
| 510k Number | K192993 |
| Device Name: | SCARLET AL-T |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Spineart 3 Chemin Du Pré Fleuri 1228 Plan Les Ouates Geneva, CH |
| Contact | Franck Pennesi |
| Correspondent | Franck Pennesi Spineart 3 Chemin Du Pré Fleuri 1228 Plan Les Ouates Geneva, CH |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-25 |
| Decision Date | 2020-01-22 |