The following data is part of a premarket notification filed by Spineart with the FDA for Juliet Ti.
| Device ID | K181203 |
| 510k Number | K181203 |
| Device Name: | Juliet Ti |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Spineart 3 Chemin Du Pré Fleuri Plan Les Ouates, CH 1228 |
| Contact | Frank Pennesi |
| Correspondent | Frank Pennesi Spineart 3 Chemin Du Pré Fleuri Plan Les Ouates, CH 1228 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-06-28 |
| Summary: | summary |