FDA Registration
Active
🇨🇭 Switzerland
Naviswiss Knee Navigation System
Reg #: 3017123055
·
FEI: 3017123055
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NAVISWISS AG
- Registration Number
- 3017123055
- FEI Number
- 3017123055
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- stahlrain 2
- City
- Brugg Aargau
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K223351
Owner / Operator
- Firm Name
- Naviswiss AG
- Operator Number
- 10076290
- Address
- stahlrain 2
- City
- Brugg
- State
- CH-NOTA
- Postal Code
- 5200
- Country
- CH
- Correspondent
- Jan Stifter
US Agent
- Business Name
- confinis USA Inc.
- Contact Name
- Alfred Lerch
- Address
- 600 Park Offices Drive Suite 300, Unit #50
- City
- Durham
- State
- NC
- ZIP
- 27709
- Country
- US
- [email protected]
- Phone
- 910 2289391
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-02-06 |
Proprietary Names
Naviswiss Knee Navigation System
Naviswiss Knee
Establishment Types
Manufacture Medical Device