BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    EXTENDED HA PIN 6MM 35MM X 150MM (71076535)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    34
    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
    K210784

    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
    Pin, Fixation, Threaded JDW

    Proprietary Names

    EXTENDED HA PIN 6MM 35MM X 150MM (71076535) EXTENDED HA PIN 6MM 15MM X 150MM (71076515) EXTENDED HA PIN 6MM 45MM X 150MM (71076545) EXTENDED HA PIN 6MM 15MM X 200MM (71076015) EXTENDED HA PIN 6MM 25MM X 200MM (71076025) EXTENDED HA PIN 4.5MM 15MM X 150MM (71074515) EXTENDED HA PIN 6MM 65MM X 200MM (71076065) EXTENDED HA PIN 4.5MM 20MM X 150MM (71074520) EXTENDED HA PIN 6MM 55MM X 150MM (71076555) EXTENDED HA PIN 4.5MM 25MM X 150MM (71074525) EXTENDED HA PIN 6MM 50MM X 150MM (71076550) EXTENDED HA PIN 4.5MM 35MM X 150MM (71074535) EXTENDED HA PIN 6MM 25MM X 150MM (71076525) EXTENDED HA PIN 6MM 55MM X 200MM (71076055) EXTENDED HA PIN 4.5MM 40MM X 150MM (71074540) EXTENDED HA PIN 6MM 60MM X 200MM (71076060) EXTENDED HA PIN 6MM 30MM X 200MM (71076030) EXTENDED HA PIN 6MM 70MM X 150MM (71076570) EXTENDED HA PIN 6MM 30MM X 150MM (71076530) EXTENDED HA PIN 6MM 45MM X 200MM (71076045) EXTENDED HA PIN 4.5MM 30MM X 150MM (71074530) EXTENDED HA PIN 6MM 40MM X 200MM (71076040) EXTENDED HA PIN 6MM 60MM X 150MM (71076560) EXTENDED HA PIN 6MM 40MM X 150MM (71076540) EXTENDED HA PIN 6MM 20MM X 150MM (71076520) EXTENDED HA PIN 6MM 35MM X 200MM (71076035) EXTENDED HA PIN 4.5MM 50MM X 150MM (71074550) EXTENDED HA PIN 6MM 65MM X 150MM (71076565) EXTENDED HA PIN 6MM 50MM X 200MM (71076050) EXTENDED HA PIN 4.5MM 10MM X 150MM (71074510) EXTENDED HA PIN 6MM 20MM X 200MM (71076020) EXTENDED HA PIN 6MM 80MM X 200MM (71076080) EXTENDED HA PIN 6MM 90MM X 200MM (71076090) EXTENDED HA PIN 6MM 70MM X 200MM (71076070)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)