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    FDA Registration Active 🇲🇾 Malaysia

    CORTICAL SCREW FULL 4X68MMORTHOLOC™ 3DI PLATING SYSTEM (58924068)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    2

    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
    K163044

    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
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    CORTICAL SCREW FULL 4X68MMORTHOLOC™ 3DI PLATING SYSTEM (58924068) CORTICAL SCREW FULL 4X70MMORTHOLOC™ 3DI PLATING SYSTEM (58924070) CORTICAL SCREW FULL 4X56MMORTHOLOC™ 3DI PLATING SYSTEM (58924056) CORTICAL SCREW FULL 4X42MMORTHOLOC™ 3DI PLATING SYSTEM (58924042) CORTICAL SCREW FULL 4X46MMORTHOLOC™ 3DI PLATING SYSTEM (58924046) CORTICAL SCREW FULL 4X62MMORTHOLOC™ 3DI PLATING SYSTEM (58924062) CORTICAL SCREW FULL 4X58MMORTHOLOC™ 3DI PLATING SYSTEM (58924058) CORTICAL SCREW FULL 4X44MMORTHOLOC™ 3DI PLATING SYSTEM (58924044) CORTICAL SCREW FULL 4X52MMORTHOLOC™ 3DI PLATING SYSTEM (58924052) CORTICAL SCREW FULL 4X64MMORTHOLOC™ 3DI PLATING SYSTEM (58924064) CORTICAL SCREW FULL 4X54MMORTHOLOC™ 3DI PLATING SYSTEM (58924054) CORTICAL SCREW FULL 4X48MMORTHOLOC™ 3DI PLATING SYSTEM (58924048) CORTICAL SCREW FULL 4X66MMORTHOLOC™ 3DI PLATING SYSTEM (58924066)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)