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 |