FDA Registration
Active
🇲🇾 Malaysia
Exprt Revision Hip, Capture Bolt Trial, 65mm (803-95-265)
Reg #: 3012217062
·
FEI: 3012217062
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- STRAITS ORTHOPAEDICS (MFG) SDN BHD
- Registration Number
- 3012217062
- FEI Number
- 3012217062
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No 2483 Tingkat Perusahaan 4A, Prai Free Industrial Zone
- City
- Perai Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K163497
Owner / Operator
- Firm Name
- Straits Orthopaedics (Mfg) Sdn Bhd
- Operator Number
- 10048319
- Address
- No. 2 Lengkok Teluk Kumbar, Jalan Teluk Kumbar
- City
- Bayan Lepas
- State
- Pulau Pinang
- Postal Code
- 11920
- Country
- MY
- Correspondent
- TH SU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2018-09-04 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-09-04 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2018-09-04 |
Proprietary Names
Exprt Revision Hip, Capture Bolt Trial, 65mm (803-95-265)
Exprt Revision Hip, Capture Bolt Trial, 75mm (803-95-275)
Exprt Revision Hip, Capture Bolt Trial, 85mm (803-95-285)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)