The following data is part of a premarket notification filed by Spineart with the FDA for Scarlet Ac-t.
| Device ID | K172065 |
| 510k Number | K172065 |
| Device Name: | SCARLET AC-T |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | SPINEART 3 Chemin Du Pre Fleuri Plan Les Ouates, CH 1228 |
| Contact | Franck Pennesi |
| Correspondent | Franck Pennesi SPINEART 3 Chemin Du Pre Fleuri Plan Les Ouates, CH 1228 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-07 |
| Decision Date | 2017-09-29 |
| Summary: | summary |