FDA Registration
Active
🇲🇾 Malaysia
151472 SALVATION BOLT 5 X [TAB]
Reg #: 3012217062
·
FEI: 3012217062
·
Expires 2025
Products
1
Proprietary Names
122
Establishment Types
1
Classifications
1
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
- K140741
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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-02-25 |
Proprietary Names
151472 SALVATION BOLT 5 X [TAB]
SB005095 SALVATION BOLT 5 X [TAB]
SB065195, SB065200 SALVATION BOLT 6.5 X [TAB]
151444 - 151455, 151457 - 151463 SALVATION BOLT 6.5 X [TAB]
SB017065 SALVATION BEAM 7 X [TAB] FULL THREAD
SB005055 SALVATION BOLT 5 X [TAB]
SB050115 SALVATION BOLT 5 X [TAB]
151526 SALVATION BEAM 7 X [TAB] FULL THREAD
151495 SALVATION BOLT 7 X [TAB]
SBS07060 SALVATION BEAM 7 X [TAB]
151493 SALVATION BOLT 7 X [TAB]
SB007075 SALVATION BOLT 7 X [TAB]
SB007095 SALVATION BOLT 7 X [TAB]
SB050120 SALVATION BOLT 5 X [TAB]
SB070190, SB070195, SB070200 SALVATION BEAM 7 X [TAB]
151492 SALVATION BOLT 7 X [TAB]
151466 SALVATION BOLT 5 X [TAB]
SB050105 SALVATION BOLT 5 X [TAB]
151438 SALVATION BOLT 6.5 X [TAB]
SB007085 SALVATION BOLT 7 X [TAB]
151477 SALVATION BOLT 5 X [TAB]
151511 SALVATION BEAM 7 X [TAB]
151487 SALVATION BOLT 7 X [TAB]
SB005050 SALVATION BOLT 5 X [TAB]
151528 - 151540, 151543 - 151548, SALVATION BEAM 7 X [TAB] FULL THREAD
151467 SALVATION BOLT 5 X [TAB]
151465 SALVATION BOLT 5 X [TAB]
SB070100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 175, 180, 185, SALVATION BEAM 7 X [TAB]
SB017075 SALVATION BEAM 7 X [TAB] FULL THREAD
151497 - 151509, 151512 - 151517 SALVATION BEAM 7 X [TAB]
151442 SALVATION BOLT 6.5 X [TAB]
151464 SALVATION BOLT 5 X [TAB]
SB005065 SALVATION BOLT 5 X [TAB]
SB017085 SALVATION BEAM 7 X [TAB] FULL THREAD
SBS07065 SALVATION BEAM 7 X [TAB]
SB006560 SALVATION BOLT 6.5 X [TAB]
151440 SALVATION BOLT 6.5 X [TAB]
SB170185, SB170190, SB170195, SB170200 SALVATION BEAM 7 X [TAB] FULL THREAD
SBS06595 SALVATION BOLT 6.5 X [TAB]
151439 SALVATION BOLT 6.5 X [TAB]
151434 SALVATION BOLT 6.5 X [TAB]
SBS06580 SALVATION BOLT 6.5 X [TAB]
151522 SALVATION BEAM 7 X [TAB] FULL THREAD
SB006550 SALVATION BOLT 6.5 X [TAB]
151469 SALVATION BOLT 5 X [TAB]
SB050100 SALVATION BOLT 5 X [TAB]
151468 SALVATION BOLT 5 X [TAB]
SB017080 SALVATION BEAM 7 X [TAB] FULL THREAD
151441 SALVATION BOLT 6.5 X [TAB]
151478 - 151486 SALVATION BOLT 5 X [TAB]
151471 SALVATION BOLT 5 X [TAB]
151527 SALVATION BEAM 7 X [TAB] FULL THREAD
SBS07055 SALVATION BEAM 7 X [TAB]
151456 SALVATION BOLT 6.5 X [TAB]
SB007055 SALVATION BOLT 7 X [TAB]
SB065145, SB065150, SB065155, SB065160, SB065170, SB065175, SB065180, SB065185, SB065190, SALVATION BOLT 6.5 X [TAB]
SBS05050, 55, 60, 65, 70, 75, 80, 85, 90, 95, SBS06550 SALVATION BOLT 5 X [TAB]
SBS07075 SALVATION BEAM 7 X [TAB]
SB006570 SALVATION BOLT 6.5 X [TAB]
151519 SALVATION BEAM 7 X [TAB] FULL THREAD
SBS06590 SALVATION BOLT 6.5 X [TAB]
SBS07085 SALVATION BEAM 7 X [TAB]
151436 SALVATION BOLT 6.5 X [TAB]
151524 SALVATION BEAM 7 X [TAB] FULL THREAD
151496 SALVATION BOLT 7 X [TAB]
SB005060 SALVATION BOLT 5 X [TAB]
SBS06555 SALVATION BOLT 6.5 X [TAB]
151491 SALVATION BOLT 7 X [TAB]
151488 SALVATION BOLT 7 X [TAB]
SBS07070 SALVATION BEAM 7 X [TAB]
SBS06585 SALVATION BOLT 6.5 X [TAB]
151510 SALVATION BEAM 7 X [TAB]
SB005090 SALVATION BOLT 5 X [TAB]
SB005080 SALVATION BOLT 5 X [TAB]
151475 SALVATION BOLT 5 X [TAB]
SB007060 SALVATION BOLT 7 X [TAB]
SB017050 SALVATION BEAM 7 X [TAB] FULL THREAD
SBS06575 SALVATION BOLT 6.5 X [TAB]
SB017090 SALVATION BEAM 7 X [TAB] FULL THREAD
SB006565 SALVATION BOLT 6.5 X [TAB]
SB017055 SALVATION BEAM 7 X [TAB] FULL THREAD
SBS07095 SALVATION BEAM 7 X [TAB]
151490 SALVATION BOLT 7 X [TAB]
SB006590 SALVATION BOLT 6.5 X [TAB]
SB006580 SALVATION BOLT 6.5 X [TAB]
SBS50100 SALVATION BEAM 5 X [TAB]
SB005075 SALVATION BOLT 5 X [TAB]
SB007050 SALVATION BOLT 7 X [TAB]
SB017070 SALVATION BEAM 7 X [TAB] FULL THREAD
151470 SALVATION BOLT 5 X [TAB]
151474 SALVATION BOLT 5 X [TAB]
151520 SALVATION BEAM 7 X [TAB] FULL THREAD
SB050125 - SB050160 SALVATION BOLT 5 X [TAB]
SB007070 SALVATION BOLT 7 X [TAB]
SB006575 SALVATION BOLT 6.5 X [TAB]
SB065100, SB065105, SB065110, SB065115, SB065120, SB065125, SB065130, SB065135, SB065140 SALVATION BOLT 6.5 X TAB
SB006555 SALVATION BOLT 6.5 X [TAB]
151435 SALVATION BOLT 6.5 X [TAB]
SBS07080 SALVATION BEAM 7 X [TAB]
151523 SALVATION BEAM 7 X [TAB] FULL THREAD
151437 SALVATION BOLT 6.5 X [TAB]
151473 SALVATION BOLT 5 X [TAB]
151525 SALVATION BEAM 7 X [TAB] FULL THREAD
151489 SALVATION BOLT 7 X [TAB]
151433 SALVATION BOLT 6.5 X [TAB]
SBS07050 SALVATION BOLT 6.5 X [TAB]
SB017095 SALVATION BEAM 7 X [TAB] FULL THREAD
SB005085 SALVATION BOLT 5 X [TAB]
SB006595 SALVATION BOLT 6.5 X [TAB]
SB170100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 175, 180, SALVATION BEAM 7 X [TAB] FULL THREAD
151518 SALVATION BEAM 7 X [TAB] FULL THREAD
SB007080 SALVATION BOLT 7 X [TAB]
SB050110 SALVATION BOLT 5 X [TAB]
151494 SALVATION BOLT 7 X [TAB]
SB007065 SALVATION BOLT 7 X [TAB]
151476 SALVATION BOLT 5 X [TAB]
SB007090 SALVATION BOLT 7 X [TAB]
SB006585 SALVATION BOLT 6.5 X [TAB]
151564 - 151573 SALVATION BOLT 5 X [TAB]
SB005070 SALVATION BOLT 5 X [TAB]
SB017060 SALVATION BEAM 7 X [TAB] FULL THREAD
SBS07090 SALVATION BEAM 7 X [TAB]
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)