FDA Registration
Active
🇮🇹 Italy
SMR TT Augmented Glenoid System
Reg #: 3013791180
·
FEI: 3013791180
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OEB S.R.L.
- Registration Number
- 3013791180
- FEI Number
- 3013791180
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Circonvallazione, 9
- City
- Camposanto Modena
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K200171
Owner / Operator
- Firm Name
- OEB S.r.l.
- Operator Number
- 10092438
- Address
- Via Circonvallazione, 9
- City
- Camposanto
- State
- Modena
- Postal Code
- 41031
- Country
- IT
- Correspondent
- Andrea Dondi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-02-14 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2025-02-14 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-02-14 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2025-02-14 |
Proprietary Names
SMR TT Augmented Glenoid System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)