FDA Registration
Active
🇺🇸 United States
Femurs
Reg #: 3020703621
·
FEI: 3020703621
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- MACH MEDICAL
- Registration Number
- 3020703621
- FEI Number
- 3020703621
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4707 East Park 30 Drive
- City
- Columbia City
- State
- IN
- ZIP
- 46725
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093552
Owner / Operator
- Firm Name
- Mach Medical, LLC
- Operator Number
- 10082639
- Address
- 4707 East Park 30 Drive
- City
- Columbia City
- State
- IN
- Postal Code
- 46725
- Country
- US
- Correspondent
- Steven J Leins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2023-12-15 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2023-12-15 |
Proprietary Names
Femurs
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)