FDA Registration
Active
🇺🇸 United States
VERSA-DIAL HUMERAL HEAD PROSTHESIS
Reg #: 3004976965
·
FEI: 3004976965
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Viant Medical, LLC
- Registration Number
- 3004976965
- FEI Number
- 3004976965
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4545 Kroemer Rd
- City
- Fort Wayne
- State
- IN
- ZIP
- 46818
- Country
- US
Regulatory Submissions
- 510(k) Number
- K060716
Owner / Operator
- Firm Name
- Viant Medical, LLC
- Operator Number
- 9043339
- Address
- 2 Hampshire Street, Suite 202
- City
- Foxborough
- State
- MA
- Postal Code
- 02035
- Country
- US
- Correspondent
- David - Rose
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2020-08-11 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2020-08-11 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2020-08-11 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-08-11 |
Proprietary Names
VERSA-DIAL HUMERAL HEAD PROSTHESIS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)