BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    41122714 MTP HEX SCREW 2.7MM X 14MM

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    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
    K141417

    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

    Proprietary Names

    41122714 MTP HEX SCREW 2.7MM X 14MM 41122720 MTP HEX SCREW 2.7MM X 20MM 41122726 MTP HEX SCREW 2.7MM X 26MM 41122718 MTP HEX SCREW 2.7MM X 18MM 41122730 MTP HEX SCREW 2.7MM X 30MM 41122724 MTP HEX SCREW 2.7MM X 24MM 41122728 MTP HEX SCREW 2.7MM X 28MM MTP Hex Screw 2.7mm X 18mm Charlotte™ F&A System (41122718) MTP Hex Screw 2.7mm X 22mm Charlotte™ F&A System (41122722) 41122712 MTP HEX SCREW 2.7MM X 12MM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)