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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640450867711 | K203222 | 000 |
| 07640450867582 | K203222 | 000 |
| 07640450867575 | K203222 | 000 |
| 07640450867568 | K203222 | 000 |
| 07640450867551 | K203222 | 000 |
| 07640450867544 | K203222 | 000 |
| 07640450867537 | K203222 | 000 |
| 07640450867520 | K203222 | 000 |
| 07640450867513 | K203222 | 000 |
| 07640450867506 | K203222 | 000 |
| 07640450867490 | K203222 | 000 |
| 07640450867599 | K203222 | 000 |
| 07640450867605 | K203222 | 000 |
| 07640450867704 | K203222 | 000 |
| 07640450867698 | K203222 | 000 |
| 07640450867681 | K203222 | 000 |
| 07640450867674 | K203222 | 000 |
| 07640450867667 | K203222 | 000 |
| 07640450867650 | K203222 | 000 |
| 07640450867643 | K203222 | 000 |
| 07640450867636 | K203222 | 000 |
| 07640450867629 | K203222 | 000 |
| 07640450867612 | K203222 | 000 |
| 07640450867483 | K203222 | 000 |