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    FDA Registration Active 🇲🇾 Malaysia

    MUC SCREW 3 X 10MM CHARLOTTE™ F&A SYSTEM (44110001)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    42
    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
    K043102

    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

    MUC SCREW 3 X 10MM CHARLOTTE™ F&A SYSTEM (44110001) MUC SCREW 3 X 26MM (44110009) MUC SCREW 3 X 14MM (44110003) MUC SCREW 3 X 12MM (44110002) MUC SCREW 4.3MM X 55MM LONG (44110041) MUC SCREW 3 X 24MM (44110008) MUC SCREW 4.3MM X 60MM LONG (44110042) MUC SCREW 4.3MM X 42MM LONG (44110036) MUC SCREW 4.3MM X 38MM SHORT (44110026) MUC SCREW 4.3MM X 20MM SHORT (44110017) MUC SCREW 4.3MM X 40MM SHORT (44110027) MUC SCREW 3 X 34MM CHARLOTTE™ F&A SYSTEM (44110013) MUC SCREW 4.3MM X 36MM LONG (44110033) MUC SCREW 4.3MM X 22MM SHORT (44110018) MUC SCREW 3 X 22MM (44110007) MUC SCREW 4.3MM X 30MM SHORT (44110022) MUC SCREW 4.3MM X 26MM SHORT (44110020) MUC SCREW 3 X 20MM (44110006) MUC SCREW 4.3MM X 40MM LONG (44110035) MUC SCREW 4.3MM X 14MM SHORT (44110014) MUC SCREW 4.3MM X 48MM SHORT (44110031) MUC SCREW 3 X 28MM (44110010) MUC SCREW 4.3MM X 48MM LONG (44110039) MUC SCREW 4.3MM X 18MM SHORT (44110016) MUC SCREW 3 X 16MM (44110004) MUC SCREW 3 X 32MM (44110012) MUC SCREW 3 X 18MM (44110005) MUC SCREW 4.3MM X 38MM LONG (44110034) MUC SCREW 4.3MM X 34MM SHORT (44110024) MUC SCREW 4.3MM X 50MM LONG (44110040) MUC SCREW 4.3MM X 46MM SHORT (44110030) MUC SCREW 3 X 30MM (44110011) MUC SCREW 4.3MM X 28MM SHORT (44110021) MUC SCREW 4.3MM X 50MM SHORT (44110032) MUC SCREW 4.3MM X 24MM SHORT (44110019) MUC SCREW 4.3MM X 44MM SHORT (44110029) MUC SCREW 4.3MM X 32MM SHORT (44110023) MUC SCREW 4.3MM X 16MM SHORT (44110015) MUC SCREW 4.3MM X 46MM LONG (44110038) MUC SCREW 4.3MM X 42MM SHORT (44110028) MUC SCREW 4.3MM X 36MM SHORT (44110025) MUC SCREW 4.3MM X 44MM LONG (44110037)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)