FDA Registration
Active
🇬🇧 United Kingdom
BIRMINGHAM HIP Dual Mobility Insert
Reg #: 3005975929
·
FEI: 3005975929
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SMITH & NEPHEW ORTHOPAEDICS LTD.
- Registration Number
- 3005975929
- FEI Number
- 3005975929
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- AURORA HOUSE, SPA PARK, HARRISON WAY
- City
- LEAMINGTON SPA Warwickshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K171934
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, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2017-12-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2017-12-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2017-12-05 |
Proprietary Names
BIRMINGHAM HIP Dual Mobility Insert
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility