FDA Registration
Active
🇺🇸 United States
JOURNEY II Unicompartmental Knee System
Reg #: 3005551626
·
FEI: 3005551626
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SMITH & NEPHEW, INC.
- Registration Number
- 3005551626
- FEI Number
- 3005551626
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6409 E Holmes Rd
- City
- Memphis
- State
- TN
- ZIP
- 38141
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242711
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, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2024-11-01 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2024-11-01 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2024-11-01 |
Proprietary Names
JOURNEY II Unicompartmental Knee System
Establishment Types
Manufacture Medical Device