FDA Registration
Active
🇺🇸 United States
TAPERLOC COMPLETE, SIZE 4MM & XR 123
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
- K120030
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 Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-04-05 |
Proprietary Names
TAPERLOC COMPLETE, SIZE 4MM & XR 123
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)