The following data is part of a premarket notification filed by Spine Art with the FDA for Romeo Posterior Osteosynthesis System Prebent Cross-connectors; Prebent Rods.
| Device ID | K141835 |
| 510k Number | K141835 |
| Device Name: | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINE ART 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Contact | Franck Pennesi |
| Correspondent | Franck Pennesi SPINE ART 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2014-09-10 |
| Summary: | summary |