FDA Registration
Active
🇺🇸 United States
G7 Acetabular System
Reg #: 3004153896
·
FEI: 3004153896
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
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
- K121874
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 |
|---|---|---|---|---|---|
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2021-03-16 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2021-03-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-03-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-03-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2021-03-16 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2021-03-16 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2021-03-16 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2021-03-16 |
Proprietary Names
G7 Acetabular System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)