FDA Registration
Active
🇫🇷 France
32mm Glenosphere and Humeral Cup
Reg #: 3009532798
·
FEI: 3009532798
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Fx Shoulder Solutions SAS
- Registration Number
- 3009532798
- FEI Number
- 3009532798
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1663 rue de Majornas
- City
- Viriat Auvergne-Rhone-Alpes
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K192206
Owner / Operator
- Firm Name
- FX Shoulder Solutions
- Operator Number
- 10039598
- Address
- 1663 rue de Majornas
- City
- Viriat
- State
- FR-NOTA
- Postal Code
- 01440
- Country
- FR
- Correspondent
- Sabrina Gental
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2019-12-30 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2019-12-30 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2019-12-30 |
Proprietary Names
32mm Glenosphere and Humeral Cup
Establishment Types
Manufacture Medical Device