The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Discectomy Navigation Ready Instruments And Universal Navigation Adaptor Set.
| Device ID | K212756 |
| 510k Number | K212756 |
| Device Name: | Discectomy Navigation Ready Instruments And Universal Navigation Adaptor Set |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MEDOS International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Nicole Aeschbacher |
| Correspondent | Nicole Aeschbacher MEDOS International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-31 |
| Decision Date | 2022-05-05 |