The following data is part of a premarket notification filed by Spineart Sa with the FDA for Spineart Navigation Instrument System.
| Device ID | K183630 |
| 510k Number | K183630 |
| Device Name: | SPINEART Navigation Instrument System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Spineart SA Chemin Du Pre- Fleuri 3 Plan-les-ouates, CH 1228 |
| Contact | Franck Pennesi |
| Correspondent | Meredith Lee May Empirical Consulting LLC 4628 Northpark Dr Colorado Springs, CO 80918 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-06-10 |