FDA Registration
Active
🇺🇸 United States
R3 Acetabular System
Reg #: 1020279
·
FEI: 1020279
·
Expires 2025
Products
8
Proprietary Names
6
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- SMITH & NEPHEW, INC.
- Registration Number
- 1020279
- FEI Number
- 1020279
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1450 BROOKS RD.
- City
- MEMPHIS
- State
- TN
- ZIP
- 38116
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240783
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, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2024-11-11 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2024-11-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2024-11-11 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2024-11-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2024-11-11 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2024-11-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-11-11 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2024-11-11 |
Proprietary Names
R3 Acetabular System
Anthology Hip Stems
Synergy Hip Stems
Spectron Hip Stems
CPCS Hip Stems
Femoral Heads
Establishment Types
Manufacture Medical Device