The following data is part of a premarket notification filed by Spineart with the FDA for Tryptik Ti.
| Device ID | K200312 |
| 510k Number | K200312 |
| Device Name: | Tryptik Ti |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Spineart 3 Chemin Du Pre Fleuri Plan Les Ouates, CH 1228 |
| Contact | Frank Pennesi |
| Correspondent | Frank 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 | 2020-02-06 |
| Decision Date | 2020-04-06 |