The following data is part of a premarket notification filed by Spineart with the FDA for Tryptik2 C-plate Anterior Cervical Plate System.
| Device ID | K171797 |
| 510k Number | K171797 |
| Device Name: | TRYPTIK2 C-Plate Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| 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 | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-16 |
| Decision Date | 2018-02-26 |
| Summary: | summary |