The following data is part of a premarket notification filed by Naviswiss Ag with the FDA for Naviswiss Hip Navigation System.
| Device ID | K193094 |
| 510k Number | K193094 |
| Device Name: | Naviswiss Hip Navigation System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Naviswiss AG Stahlrain 2 Brugg, CH 5200 |
| Contact | Jan Stifter |
| Correspondent | Viky Verna confinis 15807 Glacier Ct Potomac, MD 20878 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-07 |
| Decision Date | 2020-06-10 |