FDA Registration
Active
🇲🇾 Malaysia
125 Trochanteric Antegrade Nail (Right Purple, Tan) 11.5mm x 40cm (1451955)
Reg #: 3004889950
·
FEI: 3004889950
·
Expires 2025
Products
1
Proprietary Names
78
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
- K040462
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 | 2015-05-12 |
Proprietary Names
125 Trochanteric Antegrade Nail (Right Purple, Tan) 11.5mm x 40cm (1451955)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 8.5mm x 34cm (81043087)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 10mm x 38cm (81011863)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 8.5mm x 30cm (81043085)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 13mm x 38cm (81011834)
125 Trochanteric Antegrade Nail (Left Green, Tan) 10mm x 36cm (1451776)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 13mm x 44cm (81011966)
125 Trochanteric Antegrade Nail (Right Purple, Tan) 10mm x 36cm (1451851)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 10mm x 40cm (81011866)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 11.5mm x 42cm (81011943)
125 Trochanteric Antegrade Nail (Left Green, Tan) 10mm x 38cm (1451779)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 11.5mm x 36cm (81011941)
125 Trochanteric Antegrade Nail (Right Purple, Tan) 11.5mm x 38cm (1451952)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 13mm x 44cm (81011837)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 11.5mm x 34cm (81011906)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 11.5mm x 44cm (81011911)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 10mm x 34cm (81011856)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 13mm x 38cm (81011963)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 11.5mm x 40cm (81011909)
125 Trochanteric Antegrade Nail (Left Green, Tan) 11.5mm x 36cm (1451884)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 8.5mm x 32cm (81043086)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 11.5mm x 32cm (81011939)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 10mm x 34cm (81011884)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 13mm x 36cm (81011833)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 10mm x 36cm (81011885)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 13mm x 40cm (81011964)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 11.5mm x 32cm (81011905)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 13mm x 32cm (81011960)
130 Trochanteric Antegrade Nail 11.5mm x 34cm Left (71647334)
130 Trochanteric Antegrade Nail 11.5mm x 38cm Left (71647338)
125 Trochanteric Antegrade Nail (Left Green, Tan) 10mm x 42cm (1451785)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 10mm x 44cm (81011870)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 13mm x 34cm (81011961)
125 Trochanteric Antegrade Nail (Left Green, Tan) 11.5mm x 34cm (1451881)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 10mm x 40cm (81011887)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 10mm x 42cm (81011868)
130 Trochanteric Antegrade Nail 10mm x 44 cm Right (71648244)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 8.5mm x 26cm (81043083)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 10mm x 32cm (81011854)
Trochanteric Antegrade Nail (Right Purple Tan) 11.5mm x 40cm (71638340)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 10mm x 44cm (81011889)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 10mm x 42cm (81011888)
125 Trochanteric Antegrade Nail (Right Purple, Tan) 11.5mm x 36cm (1451949)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 8.5mm x 24cm (81043082)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 11.5mm x 38cm (81012034)
125 Trochanteric Antegrade Nail (Left Green, Tan) 10mm x 32cm (1451770)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 11.5mm x 36cm (81011907)
125 Trochanteric Antegrade Nail (Left Green, Tan) 11.5mm x 42cm (1451892)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 8.5mm x 42cm (81043091)
125 Trochanteric Antegrade Nail (Right Purple, Tan) 11.5mm x 42cm (1451958)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 13mm x 36cm (81011962)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 8.5mm x 40cm (81043090)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 11.5mm x 42cm (81011910)
130 Trochanteric Antegrade Nail (Left Lime/Tan) 13mm x 32cm (81011831)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 8.5mm x 38cm (81043089)
125 Trochanteric Antegrade Nail (Left Green, Tan) 10mm x 40cm (1451782)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 11.5mm x 38cm (81011908)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 8.5mm x 36cm (81043088)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 13mm x 42cm (81011965)
125 Trochanteric Antegrade Nail (Left Green, Tan) 10mm x 34cm (1451773)
125 Trochanteric Antegrade Nail (Left Green, Tan) 11.5mm x 38cm (1451887)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 11.5mm x 40cm (81011942)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 10mm x 36cm (81011858)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 11.5mm x 34cm (81011940)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 10mm x 38cm (81011886)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 10mm x 32cm (81011883)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 11.5mm x 44cm (81011944)
125 Trochanteric Antegrade Nail (Left Green, Tan) 11.5mm x 40cm (1451890)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 13mm x 40cm (81011835)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 13mm x 34cm (81011832)
130 Trochanteric Antegrade Nail (Rifgt Rose, Tan) 11.5mm x 38cm (71648338)
125 Trochanteric Antegrade Nail (Right Purple, Tan) 10mm x 34cm (1451848)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 13mm x 42cm (81011836)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 8.5mm x 28cm (81043084)
130 Trochanteric Antegrade Nail (Right Rose, Tan) 11.5mm x 44cm (71648344)
130 Trochanteric Antegrade Nail (Left Lime, Tan) 13mm x 48cm (71647448)
130 Trochanteric Antegrade Nail 11.5mm x 40cm Right (71648340)
Trochanteric Antegrade Nail (Left Green/Tan) 11.5mm x 40cm (71637340)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)