FDA Registration
Active
🇺🇸 United States
Real Intelligence CORI
Reg #: 1219602
·
FEI: 1219602
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- SMITH & NEPHEW INC.
- Registration Number
- 1219602
- FEI Number
- 1219602
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ENDOSCOPY, 120 FORBES BLVD. SUITE 150 / 130 FORBES BLVD.
- City
- MANSFIELD
- State
- MA
- ZIP
- 02048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240139
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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2024-03-28 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2024-03-28 |
| Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer | NJD | Class 2 | Orthopedic | No | 2024-03-28 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-03-28 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-03-28 |
Proprietary Names
Real Intelligence CORI
Establishment Types
Manufacture Medical Device