BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    7 MUC SCREW 90MM X 16MM (44179016)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    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
    K070525

    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 MUC SCREW 90MM X 16MM (44179016) 7 MUC SCREW 60MM X 16MM (44176016) 7 MUC SCREW 95MM X 16MM (44179516) 7 MUC SCREW 75MM X 32MM (44177532) 7 MUC SCREW 105MM X 16MM (44170516) 7 MUC SCREW 40MM X 16MM (44174016) 7 MUC SCREW 85MM X 32MM (44178532) 7 MUC SCREW 100MM X 32MM (44170032) 7 MUC SCREW 90MM X 32MM (44179032) 7 MUC SCREW 80MM X 32MM (44178032) 7 MUC SCREW 75MM X 16MM (44177516) 7 MUC SCREW 65MM X 16MM (44176516) 7 MUC SCREW 110MM X 16MM (44171016) 7 MUC SCREW 50MM X 16MM (44175016) 7 MUC SCREW 85MM X 16MM (44178516) 7 MUC SCREW 55MM X 16MM (44175516) 7 MUC SCREW 95MM X 32MM (44179532) 7 MUC SCREW 100MM X 16MM (44170016) 7 MUC SCREW 70MM X 16MM (44177016) 7 MUC SCREW 45MM X 16MM (44174516) 7 MUC SCREW 105MM X 32MM (44170532) 7 MUC SCREW 80MM X 16MM (44178016) 7 MUC SCREW 110MM X 32MM (44171032)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)