FDA Registration
Active
🇺🇸 United States
SN 6125 C-C Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
Reg #: 3010386387
·
FEI: 3010386387
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- SINGLE SOURCE MEDICAL LLC
- Registration Number
- 3010386387
- FEI Number
- 3010386387
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4506 S State Road 9 57
- City
- Churubusco
- State
- IN
- ZIP
- 46723
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172502
Owner / Operator
- Firm Name
- Single Source Medical LLC
- Operator Number
- 10043888
- Address
- 4506 IN 9-57
- City
- Churubusco
- State
- IN
- Postal Code
- 46723
- Country
- US
- Correspondent
- Tom Harris
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2019-09-13 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2019-09-13 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2019-09-13 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2019-09-13 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2019-09-13 |
Proprietary Names
SN 6125 C-C Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)