FDA Registration
Active
🇲🇾 Malaysia
LS-2512 (2.5mm Locking Ti Screw X 12mm long)
Reg #: 3025603301
·
FEI: 3025603301
·
Expires 2025
Products
2
Proprietary Names
18
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- STRAITS ORTHOPAEDICS (MFG) SDN BHD
- Registration Number
- 3025603301
- FEI Number
- 3025603301
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1264, Lorong PSPN 1, Penang Science Park North
- City
- Simpang Ampat Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K140357
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
Proprietary Names
LS-2512 (2.5mm Locking Ti Screw X 12mm long)
2.5mm Locking Ti Screw X 14mm long (LS-2514)
Left Lpt Plate 6 Hole X 100mm (LPT-06100L)
3.5mm Non-Locking Ti Screw X 80mm long (ST-3580)
3.5mm Non-Locking Ti Screw X 70mm long (ST-3570)
Right Lpt Plate 6 Hole X 100mm (LPT-06100R)
3.5mm Non-Locking Ti Screw X 55mm long (ST-3555)
2.5mm Locking Ti Screw X 10mm long (LS-2510)
3.5mm Non-Locking Ti Screw X 85mm long (ST-3585)
3.5mm Non-Locking Ti Screw X 75mm long (ST-3575)
3.5mm Non-Locking Ti Screw X 60mm long (ST-3560)
3.5mm Non-Locking Ti Screw X 40mm long (ST-3540)
3.5mm Non-Locking Ti Screw X 65mm long (ST-3565)
Left Lpt Plate 8 Hole X 125mm (LPT-08125L)
3.5mm Non-Locking Ti Screw X 50mm long (ST-3550)
Right Lpt Plate 10 Hole X 150mm (LPT-10150R)
3.5mm Non-Locking Ti Screw X 45mm long (ST-3545)
2.5mm Locking Ti Screw X 16mm long (LS-2516)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)