FDA Registration
Active
🇨🇭 Switzerland
Persona Revision SoluTion Femoral Components
Reg #: 9613350
·
FEI: 3005233524
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ZIMMER GMBH
- Registration Number
- 9613350
- FEI Number
- 3005233524
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Sulzer Allee 8
- City
- WINTERTHUR Zurich
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K243724
Owner / Operator
- Firm Name
- ZIMMER GMBH
- Operator Number
- 9064978
- Address
- Zahlerweg 4
- City
- Zug
- State
- CH-ZG
- Postal Code
- 6300
- Country
- CH
US Agent
- Business Name
- Zimmer Biomet
- Contact Name
- Holly Seppanen
- Address
- 1800 West Center Street
- City
- Warsaw
- State
- IN
- ZIP
- 46580
- Country
- US
- [email protected]
- Phone
- 952 8470494
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2025-03-17 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2025-03-17 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2025-03-17 |
Proprietary Names
Persona Revision SoluTion Femoral Components
Persona® Revision Knee System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)