FDA Registration
Active
🇲🇾 Malaysia
50-01-5540 (Cannulated, Diameter 5.5mm Screw Assembly, 40mm Long)
Reg #: 3012217062
·
FEI: 3012217062
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
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
- K143230
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 |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-12-20 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2021-12-20 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-12-20 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2021-12-20 |
Proprietary Names
50-01-5540 (Cannulated, Diameter 5.5mm Screw Assembly, 40mm Long)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)