FDA Registration
Active
🇺🇸 United States
CORI
Reg #: 1643264
·
FEI: 1643264
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
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
- K201022
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, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2020-06-17 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2020-06-17 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2020-06-17 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2020-06-17 |
Proprietary Names
CORI
Establishment Types
Manufacture Medical Device