The following data is part of a premarket notification filed by Spineart with the FDA for Romeo Posterior Osteosynthesis System.
| Device ID | K112108 |
| 510k Number | K112108 |
| Device Name: | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Contact | Frank P Ennesi |
| Correspondent | Frank P Ennesi SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-22 |
| Decision Date | 2011-08-19 |
| Summary: | summary |