BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    59225555 CORTICAL SCREW 5.5 X 55MM

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    44
    Establishment Types
    1
    Classifications
    2

    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
    K121425

    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
    Screw, Fixation, Bone HWC

    Proprietary Names

    59225555 CORTICAL SCREW 5.5 X 55MM 59214522 LOCKING SCREW 4.5 X 22MM 59214550 LOCKING SCREW 4.5 X 50MM 59224524 CORTICAL SCREW 4.5 X 24MM 59214530 LOCKING SCREW 4.5 X 30MM 59214520 LOCKING SCREW 4.5 X 20MM 59225540 CORTICAL SCREW 5.5 X 40MM 59224534 CORTICAL SCREW 4.5 X 34MM 59214534 LOCKING SCREW 4.5 X 34MM 59224536 CORTICAL SCREW 4.5 X 36MM 59224530 CORTICAL SCREW 4.5 X 30MM 59225550 CORTICAL SCREW 5.5 X 50MM 59225524 CORTICAL SCREW 5.5 X 24MM 59225528 CORTICAL SCREW 5.5 X 28MM 59214560 LOCKING SCREW 4.5 X 60MM 59224555 CORTICAL SCREW 4.5 X 55MM 59214555 LOCKING SCREW 4.5 X 55MM 59214528 LOCKING SCREW 4.5 X 28MM 59225534 CORTICAL SCREW 5.5 X 34MM 59214545 LOCKING SCREW 4.5 X 45MM 59224532 CORTICAL SCREW 4.5 X 32MM 59214538 LOCKING SCREW 4.5 X 38MM 59214532 LOCKING SCREW 4.5 X 32MM 59224550 CORTICAL SCREW 4.5 X 50MM 59214540 LOCKING SCREW 4.5 X 40MM 59225536 CORTICAL SCREW 5.5 X 36MM 59225526 CORTICAL SCREW 5.5 X 26MM 59225522 CORTICAL SCREW 5.5 X 22MM 59214526 LOCKING SCREW 4.5 X 26MM 59225545 CORTICAL SCREW 5.5 X 45MM 59224560 CORTICAL SCREW 4.5 X 60MM 59225560 CORTICAL SCREW 5.5 X 60MM 59224528 CORTICAL SCREW 4.5 X 28MM 59224545 CORTICAL SCREW 4.5 X 45MM 59224540 CORTICAL SCREW 4.5 X 40MM 59224538 CORTICAL SCREW 4.5 X 38MM 59214536 LOCKING SCREW 4.5 X 36MM 59224526 CORTICAL SCREW 4.5 X 26MM 59214524 LOCKING SCREW 4.5 X 24MM 59225538 CORTICAL SCREW 5.5 X 38MM 59225530 CORTICAL SCREW 5.5 X 30MM 59225532 CORTICAL SCREW 5.5 X 32MM 59224520 Cortical Screw 4.5 x 20mm Ortholoc® System 59225520 Cortical Screw 5.5 x 20mm Ortholoc® System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)