FDA Registration
Active
🇺🇸 United States
VISIONAIRE
Reg #: 3007366790
·
FEI: 3007282753
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Smith & Nephew, Inc.
- Registration Number
- 3007366790
- FEI Number
- 3007282753
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3303 E Holmes Rd
- City
- Memphis
- State
- TN
- ZIP
- 38118
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211512
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 |
|---|---|---|---|---|---|
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2021-09-20 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2021-09-20 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2021-09-20 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-09-20 |
Proprietary Names
VISIONAIRE
Establishment Types
Manufacture Medical Device