FDA Registration
Active
🇺🇸 United States
Persona Revision Knee System
Reg #: 3004153896
·
FEI: 3004153896
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- DONSON MACHINE COMPANY
- Registration Number
- 3004153896
- FEI Number
- 3004153896
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12416 S KEDVALE AVE
- City
- ALSIP
- State
- IL
- ZIP
- 60803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191625
Owner / Operator
- Firm Name
- DONSON MACHINE COMPANY
- Operator Number
- 9057685
- Address
- 12416 S KEDVALE AVE, --
- City
- Alsip
- State
- IL
- Postal Code
- 60803
- Country
- US
- Correspondent
- JOSEPH - BETTINARDI
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2019-11-19 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-11-19 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2019-11-19 |
Proprietary Names
Persona Revision Knee System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)