The following data is part of a premarket notification filed by Spineart with the FDA for Perla® Tl Posterior Osteosynthesis System.
| Device ID | K193396 |
| 510k Number | K193396 |
| Device Name: | PERLA® TL 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 Pre Fleuri Plan Les Ouates, CH 1228 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| Subsequent Product Code | OVD |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-06 |
| Decision Date | 2020-02-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PERLA 98533824 not registered Live/Pending |
El Carmen, Inc. 2024-05-03 |
![]() PERLA 97858477 not registered Live/Pending |
2904802 Canada Inc 2023-03-27 |
![]() PERLA 97847591 not registered Live/Pending |
El Carmen, Inc. 2023-03-20 |
![]() PERLA 97748960 not registered Live/Pending |
El Carmen, Inc. 2023-01-10 |
![]() PERLA 97748932 not registered Live/Pending |
El Carmen, Inc. 2023-01-10 |
![]() PERLA 97748920 not registered Live/Pending |
El Carmen, Inc. 2023-01-10 |
![]() PERLA 97748900 not registered Live/Pending |
El Carmen, Inc. 2023-01-10 |
![]() PERLA 97748766 not registered Live/Pending |
El Carmen, Inc. 2023-01-10 |
![]() PERLA 97728735 not registered Live/Pending |
Acosta, Perla 2022-12-22 |
![]() PERLA 97728735 not registered Live/Pending |
Acosta, Perla 2022-12-22 |
![]() PERLA 97599549 not registered Live/Pending |
Perla on Broadway Homeowners Association 2022-09-20 |
![]() PERLA 97059035 not registered Live/Pending |
El Carmen, Inc. 2021-10-04 |