The following data is part of a premarket notification filed by Spineart with the FDA for Perla Tl Posterior Osteosynthesis System.
| Device ID | K203222 |
| 510k Number | K203222 |
| Device Name: | PERLA TL Posterior Osteosynthesis System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SPINEART 3 Chemin Du Pré 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 | 2020-11-02 |
| Decision Date | 2020-12-17 |