BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    HA PIN 4.5 THREAD 50 X 150MM (71070827)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    33
    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
    K023921

    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

    HA PIN 4.5 THREAD 50 X 150MM (71070827) HA PIN 4.5 THREAD 20 X 150MM (71070824) HA PIN 6MM 65MM X 150MM (71070816) HA PIN 6MM 35MM X 200MM (71070807) HA PIN 6MM 45MM X 200MM (71070836) HA PIN 6MM 25MM X 150MM (71070802) HA PIN 4.5 THREAD 40 X 150MM (71070826) HA PIN 6MM 70MM X 200MM (71070819) HA PIN 6MM 20MM X 200MM (71070801) HA PIN 6MM 65MM X 200MM (71070817) HA HALF PIN 6mm DIA X 150mm SHANK X 45mm THREAD LENGTH (71070835) HA PIN 6MM 40MM X 200MM (71070809) HA PIN 6MM 30MM X 200MM (71070805) HA PIN 4.5 THREAD 30 X 150MM (71070825) HA PIN 6MM 60MM X 150MM (71070814) HA PIN 4.5 THREAD 10 X 150MM (71070823) HA PIN 6MM 50MM X 200MM (71070811) HA PIN 6MM 15MM X 150MM (71070828) HA PIN 6MM 70MM X 150MM (71070818) HA PIN 6MM 80MM X 200MM (71070820) HA PIN 6MM 25MM X 200MM (71070803) HA PIN 6MM 35MM X 150MM (71070806) HA PIN 6MM 50MM X 150MM (71070810) HA PIN 6MM 90MM X 200MM (71070821) HA PIN 6MM 40MM X 150MM (71070808) HA PIN 6MM 45MM X 150MM (71070835) HA PIN 6MM 30MM X 150MM (71070804) HA PIN 6MM 55MM X 150MM (71070812) HA PIN, 4.5mm THREAD DIA X 150mm X 10mm THREAD LENGTH (71070823) HA PIN 6MM 20MM X 150MM (71070800) HA PIN 6MM 60MM X 200MM (71070815) HA PIN 6MM 55MM X 200MM (71070813) HA PIN 6MM 15MM X 200MM (71070829)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)