Data / Medical devices / Switzerland / Naviswiss AG
Naviswiss AG: FDA-registered device maker in Brugg Aargau, Switzerland, 3 510(k) clearances
Naviswiss AG is registered with the FDA (registration 3017123055) in Brugg Aargau, Switzerland. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 31, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017123055
- Address
- stahlrain 2, Brugg Aargau, Switzerland, 5200
- Owner or operator
- Naviswiss AG (10076290)
- Roles
- Manufacturer
- First device listed
- July 14, 2020
- Registered through
- 2026
- Brand names listed
- NS053; NAVIPLAN - CT Planning Software for Total Hip Replacement, Naviswiss Hip Navigation System, Naviswiss Knee, Naviswiss Knee Navigation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 31, 2023 | K223351 | Naviswiss Knee | OLO | Substantially Equivalent | Naviswiss AG | accessdata.fda.gov |
| October 5, 2021 | K211429 | NAVIPLAN - CT Planning Software for Total Hip Replacement | LLZ | Substantially Equivalent | Naviswiss AG | accessdata.fda.gov |
| June 10, 2020 | K193094 | Naviswiss Hip Navigation System | OLO | Substantially Equivalent | Naviswiss AG | accessdata.fda.gov |
Compare with other makers
Updated January 31, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.