BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    7.5X45MM CANN SCREW ST CSS (10-245)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    69
    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
    K042310

    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
    Screw, Fixation, Bone HWC

    Proprietary Names

    7.5X45MM CANN SCREW ST CSS (10-245) 7.5X40MM CANN SCREW SHORTLCSS (10-240) 2 X 16MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-16) 3 X14MM CANN SCREWCANNULATED SCREW SYSTEM 03-4003-14 7.5X70MM CANN SCREW SHORTLCSS (10-270) 2 X 30MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-30) 7.5X55MM CANN SCREW SHORTLCSS (10-255) 5.8X50MM CANN SCREW SHORTLCSS (10-150) 5.8X75MM CANN SCREW SHORTLCSS (10-175) 7.5X40MM CANN SCREW FULLLCSS (10-440) 2 X 9MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-09) 2 X 40MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-40) 2 X 14MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-14) 2.5 X 50MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-50 2.5 X 34MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-34 2 X 35MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-35) 5.8X54MM CANN SCREW SHORTLCSS (10-155) 2.5 X 40MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-40 3 X20MM CANN SCREWCANNULATED SCREW SYSTEM 03-4003-20 2.5 X 12MM CANN SCREWCANNULATED SCREW SYSTEM (03-4002-12) 7.5MMX50MM CANN SCREW ST CSS (10-250) 7.5X65MM CANN SCREW SHORTLCSS (10-265) 2 X 10MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-10) 2 X 17MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-17) 7.5X80MM CANN SCREW LONGLCSS (10-380) 2 X 15MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-15) 2 X 13MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-13) 2 X 20MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-20) 2.5 X 28MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-28 2.5 X 32MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-32 2 X 19MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-19) 2 X 21MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-21) 2 X 11MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-11) 7.5X65MM CANN SCREW LONGLCSS (10-365) 2.5 X 24MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-24 2 X 7MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-07) 2.5 X 38MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-38 2 X 18MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-18) 7.5X80MM CANN SCREW SHORTLCSS (10-280) 2.5 X 48MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-48 3 X16MM CANN SCREWCANNULATED SCREW SYSTEM 03-4003-16 3 X12MM CANN SCREWCANNULATED SCREW SYSTEM 03-4003-12 2 X 8MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-08) 2 X 12MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-12) 7.5X60MM CANN SCREW SHORTLCSS (10-260) 5.8X65MM CANN SCREW SHORTLCSS (10-165) 0.9MM CSS GUIDEWIRECANNULATED SCREW SYSTEM (1040-4001-0.9) 2.5 X 22MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-22 2.5 X 20MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-20 2.5 X 44MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-44 2.5 X 16MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-16 2.5 X 42MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-42 5.8X60MM CANN SCREW SHORTLCSS (10-160) 3 X18MM CANN SCREWCANNULATED SCREW SYSTEM 03-4003-18 2.5 X 30MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-30 5.8X70MM CANN SCREW SHORTLCSS (10-170) 2.5 X 46MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-46 2 X 50MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-50) 2.5 X 18MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-18 2.5 X 10MM CANN SCREWCANNULATED SCREW SYSTEM (03-4002-10) 5.8X80MM CANN SCREW SHORTLCSS (10-180) 2.5 X 36MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-36 2.5 X 14MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-14 2.5 X 26MM CANN SCREWCANNULATED SCREW SYSTEM 03-4002-26 1.1MM CSS GUIDEWIRECANNULATED SCREW SYSTEM (1040-4001-1.1) 3 X10MM CANN SCREWCANNULATED SCREW SYSTEM 03-4003-10 7.5X75MM CANN SCREW SHORTLCSS (10-275) 2 X 45MM CANN SCREWCANNULATED SCREW SYSTEM (03-4001-45) 0.9MM CSS GUIDEWIRE CANNULATED SCREW SYSTEM (1040-4001-0.9)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)