ROMEO® 2 Posterior Osteosynthesis System
Thoracolumbosacral Pedicle Screw System
Spineart
The following data is part of a premarket notification filed by Spineart with the FDA for Romeo® 2 Posterior Osteosynthesis System.
Pre-market Notification Details
| Device ID | K172101 |
| 510k Number | K172101 |
| Device Name: | ROMEO® 2 Posterior Osteosynthesis System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Spineart 3 Chemin Du Pre Fleuri Plan Les Ouates, CH 1228 |
| Contact | Franck Pennesi |
| Correspondent | Franck Pennesi Spineart 3 Chemin Du Pré Fleuri Plan Les Ouates, CH 1228 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-12 |
| Decision Date | 2017-09-26 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640178984578 | K172101 | 000 |
| 07640178984370 | K172101 | 000 |
| 07640178984363 | K172101 | 000 |
| 07640178984356 | K172101 | 000 |
| 07640178984349 | K172101 | 000 |
| 07640178984332 | K172101 | 000 |
| 07640178984325 | K172101 | 000 |
| 07640178984318 | K172101 | 000 |
| 07640178984301 | K172101 | 000 |
| 07640178984295 | K172101 | 000 |
| 07640178984288 | K172101 | 000 |
| 07640178984271 | K172101 | 000 |
| 07640178984264 | K172101 | 000 |
| 07640178984257 | K172101 | 000 |
| 07640178984240 | K172101 | 000 |
| 07640178984233 | K172101 | 000 |
| 07640178984226 | K172101 | 000 |
| 07640178984219 | K172101 | 000 |
| 07640178984387 | K172101 | 000 |
| 07640178984394 | K172101 | 000 |
| 07640178984561 | K172101 | 000 |
| 07640178984554 | K172101 | 000 |
| 07640178984547 | K172101 | 000 |
| 07640178984530 | K172101 | 000 |
| 07640178984523 | K172101 | 000 |
| 07640178984516 | K172101 | 000 |
| 07640178984509 | K172101 | 000 |
| 07640178984493 | K172101 | 000 |
| 07640178984486 | K172101 | 000 |
| 07640178984479 | K172101 | 000 |
| 07640178984462 | K172101 | 000 |
| 07640178984455 | K172101 | 000 |
| 07640178984448 | K172101 | 000 |
| 07640178984431 | K172101 | 000 |
| 07640178984424 | K172101 | 000 |
| 07640178984417 | K172101 | 000 |
| 07640178984400 | K172101 | 000 |
| 07640178984202 | K172101 | 000 |
Trademark Results [ROMEO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROMEO 98223802 not registered Live/Pending |
BARRAZA Y COMPAÃÃA, S.A. 2023-10-13 |
 ROMEO 97375139 not registered Live/Pending |
SISER s.r.l. 2022-04-21 |
 ROMEO 97235617 not registered Live/Pending |
Graham, Rich 2022-01-24 |
 ROMEO 97176708 not registered Live/Pending |
ZhangJian 2021-12-17 |
 ROMEO 90899944 not registered Live/Pending |
Cucciolo, LLC 2021-08-24 |
 ROMEO 90825627 not registered Live/Pending |
Launch Medical LLC 2021-07-13 |
 ROMEO 88962282 not registered Live/Pending |
Barraza y Compañia, S.A. 2020-06-12 |
 ROMEO 88613970 not registered Live/Pending |
Plant Development Services, Inc. 2019-09-12 |
 ROMEO 88584742 not registered Live/Pending |
Romeo Vapors Inc. 2019-08-20 |
 ROMEO 88406194 not registered Live/Pending |
LAN JIANGANG 2019-04-28 |
 ROMEO 88249037 not registered Live/Pending |
Aesthetic Management Partners, Inc. 2019-01-03 |
 ROMEO 87862715 not registered Live/Pending |
FLOS S.P.A. 2018-04-04 |
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