FDA Registration
Active
🇺🇸 United States
HARMONY
Reg #: 1643264
·
FEI: 1643264
·
Expires 2025
Products
8
Proprietary Names
6
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- SMITH & NEPHEW INC.
- Registration Number
- 1643264
- FEI Number
- 1643264
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- ENDOSCOPY, 76 S. MERIDIAN AVE.
- City
- OKLAHOMA CITY
- State
- OK
- ZIP
- 73107
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121393
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, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2013-01-07 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2013-01-07 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2013-01-07 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2013-01-07 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2013-01-07 |
| Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | KRQ | Class 2 | Orthopedic | No | 2013-01-07 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2013-01-07 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-01-07 |
Proprietary Names
HARMONY
GENESIS
LEGION
JOURNEY
PROFIX
SYNC
Establishment Types
Manufacture Medical Device