FDA Registration
Active
🇲🇾 Malaysia
330-00-020 ARSENAL DRILL TOWER 2.7/3.5/4mm OUTER SLEEVE
Reg #: 3004889950
·
FEI: 3004889950
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Straits Orthopaedics (MFG) Sdn Bhd
- Registration Number
- 3004889950
- FEI Number
- 3004889950
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2, Lengkok Teluk Kumbar 1, Jalan Teluk Kumbar
- City
- Bayan Lepas Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K212378
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 |
|---|---|---|---|---|---|
| Washer, Bolt, Nut, Non-Spinal, Metallic | NDG | Class 2 | Orthopedic | No | 2024-11-27 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2024-11-27 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-11-27 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2024-11-27 |
Proprietary Names
330-00-020 ARSENAL DRILL TOWER 2.7/3.5/4mm OUTER SLEEVE
330-00-021 ARSENAL DRILL TOWER 2.7/4mm INSERT
330-00-022 ARSENAL DRILL TOWER 3.5mm INSERT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)