The following data is part of a premarket notification filed by Spineart with the FDA for Spineart Navigation Instrument System.
| Device ID | K210472 |
| 510k Number | K210472 |
| Device Name: | SPINEART Navigation Instrument System |
| Classification | Orthopedic Stereotaxic Instrument |
| 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-17 |
| Decision Date | 2021-03-19 |