BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    SP224040 OP LOCKING SCREW 4 X 40MM

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    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
    K140792

    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

    SP224040 OP LOCKING SCREW 4 X 40MM SP235528 OSTEOPENIC SCREW 5.5 X 28MM SP224030 OP LOCKING SCREW 4 X 30MM SP235522 OSTEOPENIC SCREW 5.5 X 22MM SP235532 OSTEOPENIC SCREW 5.5 X 32MM SP234040 OSTEOPENIC SCREW 4 X 40MM SP235545 OSTEOPENIC SCREW 5.5 X 45MM SP234026 OSTEOPENIC SCREW 4 X 26MM SP224022 OP LOCKING SCREW 4 X 22MM SP235524 OSTEOPENIC SCREW 5.5 X 24MM SP224024 OP LOCKING SCREW 4 X 24MM SP235560 OSTEOPENIC SCREW 5.5 X 60MM SP224028 OP LOCKING SCREW 4 X 28MM SP234036 OSTEOPENIC SCREW 4 X 36MM SP224020 OP LOCKING SCREW 4 X 20MM SP234034 OSTEOPENIC SCREW 4 X 34MM SP224016 OP LOCKING SCREW 4 X 16MM SP224026 OP LOCKING SCREW 4 X 26MM SP224034 OP LOCKING SCREW 4 X 34MM SP234045 OSTEOPENIC SCREW 4 X 45MM SP224036 OP LOCKING SCREW 4 X 36MM SP224045 OP LOCKING SCREW 4 X 45MM SP224050 OP LOCKING SCREW 4 X 50MM SP234020 OSTEOPENIC SCREW 4 X 20MM SP224038 OP LOCKING SCREW 4 X 38MM SP235540 OSTEOPENIC SCREW 5.5 X 40MM SP224018 OP LOCKING SCREW 4 X 18MM SP235536 OSTEOPENIC SCREW 5.5 X 36MM SP234060 Osteopenic Screw 4 X 60mm Salvation™ 3Di Plating System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)