FDA Registration
Active
🇺🇸 United States
PROFIX
Reg #: 3008744062
·
FEI: 3008744062
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- Smith & Nephew, Inc.
- Registration Number
- 3008744062
- FEI Number
- 3008744062
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7135 Goodlett Farms Pkwy
- City
- Cordova
- State
- TN
- ZIP
- 38016
- Country
- US
Regulatory Submissions
- 510(k) Number
- K051229
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2015-07-31 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2015-07-31 |
Proprietary Names
PROFIX
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility