FDA Registration
Active
🇲🇾 Malaysia
INTERTAN 7MM COMPRESSION SCREW STARTER DRILL (1000276252)
Reg #: 3004889950
·
FEI: 3004889950
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
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
- K122170
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 |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2015-03-29 |
Proprietary Names
INTERTAN 7MM COMPRESSION SCREW STARTER DRILL (1000276252)
META-TAN COMPRESSION SCREW STARTER DRILL (1000276250)
Humeral Nail 8mm Broach (81016493, 71751104)
7/16 GUIDE BOLT (71674071)
UNIVERSAL META NAIL COMPRESSION DRIVER (71654528)
INTERTAN 10.5MM LAG SCREW DRILL (1000276251)
INTERTAN 10.5MM LAG SCREW DRILL (1000276249)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)