FDA Registration
Active
🇺🇸 United States
Durango
Reg #: 3004153896
·
FEI: 3004153896
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
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
- K102738
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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2012-12-17 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2012-12-17 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2012-12-17 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2012-12-17 |
Proprietary Names
Durango
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)