FDA Registration
Active
🇨🇭 Switzerland
Global Femoral Head Trial
Reg #: 9613369
·
FEI: 3002807893
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- SMITH & NEPHEW ORTHOPAEDICS AG
- Registration Number
- 9613369
- FEI Number
- 3002807893
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SCHACHENALLEE 29, DAMMWEG 39
- City
- AARAU Aargau
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K132435
Owner / Operator
- Firm Name
- Smith & Nephew, Inc.
- Operator Number
- 1020279
- Address
- 2875 Railroad Street
- City
- Pittsburgh
- State
- PA
- Postal Code
- 15222
- Country
- US
- Correspondent
- Lisa Ewing
US Agent
- Business Name
- Smith & Nephew Inc.
- Contact Name
- Lisa Ewing
- Address
- 2875 Railroad St
- City
- Pittsburgh
- State
- PA
- ZIP
- 15222
- Country
- US
- [email protected]
- Phone
- 412 4199765
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2014-05-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2014-05-19 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2014-05-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2014-05-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2014-05-19 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2014-05-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2014-05-19 |
Proprietary Names
Global Femoral Head Trial
Establishment Types
Manufacture Medical Device