The following data is part of a premarket notification filed by Spineart with the FDA for Romeo Posterior Osteosynthesis System.
| Device ID | K151695 |
| 510k Number | K151695 |
| Device Name: | Romeo Posterior Osteosynthesis System |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS, CP1813 Geneva, CH 1215 |
| Contact | Franck Pennesi |
| Correspondent | Franck Pennesi SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS, CP1813 Geneva 15, CH 1215 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-23 |
| Decision Date | 2015-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640185342460 | K151695 | 000 |
| 07640151093730 | K151695 | 000 |
| 07640151093839 | K151695 | 000 |
| 07640151093846 | K151695 | 000 |
| 07640151093860 | K151695 | 000 |
| 07640178973701 | K151695 | 000 |
| 07640178973718 | K151695 | 000 |
| 07640178973725 | K151695 | 000 |
| 07640178973732 | K151695 | 000 |
| 07640178973824 | K151695 | 000 |
| 07640178973831 | K151695 | 000 |
| 07640178973848 | K151695 | 000 |
| 07640178973855 | K151695 | 000 |
| 07640178973862 | K151695 | 000 |
| 07640151093716 | K151695 | 000 |