The following data is part of a premarket notification filed by Spineart with the FDA for Juliet Ol.
| Device ID | K140474 |
| 510k Number | K140474 |
| Device Name: | JULIET OL |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Contact | Frank Pennesi |
| Correspondent | Frank Pennesi SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-25 |
| Decision Date | 2014-04-18 |
| Summary: | summary |