FDA Registration
Active
🇲🇾 Malaysia
Smith & Nephew Hip Systems
Reg #: 3022142628
·
FEI: 3022142628
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Smith and Nephew Operations Sdn. Bhd
- Registration Number
- 3022142628
- FEI Number
- 3022142628
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PMT 797, Persiaran Cassia Selatan 8, Taman Perindustrian Batu Kawan, Bandar Cassia
- City
- Penang Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K211176
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, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2022-08-03 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2022-08-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2022-08-03 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2022-08-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2022-08-03 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2022-08-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-08-03 |
Proprietary Names
Smith & Nephew Hip Systems
Establishment Types
Manufacture Medical Device