The following data is part of a premarket notification filed by Spineart with the FDA for Romeo 2 Pad Posterior Axial Device.
| Device ID | K141508 |
| 510k Number | K141508 |
| Device Name: | ROMEO 2 PAD POSTERIOR AXIAL DEVICE |
| Classification | Spinous Process Plate |
| 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, CH 1215 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-06 |
| Decision Date | 2014-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640151087630 | K141508 | 000 |
| 07640139349316 | K141508 | 000 |
| 07640139349309 | K141508 | 000 |
| 07640139349293 | K141508 | 000 |
| 07640139349286 | K141508 | 000 |
| 07640139349279 | K141508 | 000 |
| 07640139349262 | K141508 | 000 |
| 07640139349255 | K141508 | 000 |
| 07640139349248 | K141508 | 000 |
| 07640139349323 | K141508 | 000 |
| 07640151081508 | K141508 | 000 |
| 07640151087623 | K141508 | 000 |
| 07640151087616 | K141508 | 000 |
| 07640151087609 | K141508 | 000 |
| 07640151087593 | K141508 | 000 |
| 07640151087586 | K141508 | 000 |
| 07640151081874 | K141508 | 000 |
| 07640151081867 | K141508 | 000 |
| 07640151081515 | K141508 | 000 |
| 07640139349231 | K141508 | 000 |