The following data is part of a premarket notification filed by Spineart with the FDA for Juliet Ol.
| Device ID | K101720 |
| 510k Number | K101720 |
| Device Name: | JULIET OL |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Contact | Franck Pennesi |
| Correspondent | Franck Pennesi SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-18 |
| Decision Date | 2010-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640185341661 | K101720 | 000 |
| 07640139345240 | K101720 | 000 |
| 07640139345233 | K101720 | 000 |
| 07640139345141 | K101720 | 000 |
| 07640139345134 | K101720 | 000 |
| 07640139345127 | K101720 | 000 |
| 07640139345110 | K101720 | 000 |
| 07640139345103 | K101720 | 000 |
| 07640139345097 | K101720 | 000 |
| 07640139345080 | K101720 | 000 |
| 07640139345257 | K101720 | 000 |
| 07640139345264 | K101720 | 000 |
| 07640178983557 | K101720 | 000 |
| 07640178983540 | K101720 | 000 |
| 07640178983533 | K101720 | 000 |
| 07640178975002 | K101720 | 000 |
| 07640139349972 | K101720 | 000 |
| 07640139349941 | K101720 | 000 |
| 07640139345301 | K101720 | 000 |
| 07640139345295 | K101720 | 000 |
| 07640139345288 | K101720 | 000 |
| 07640139345073 | K101720 | 000 |