BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    145361 - 145369 LOCKING CORT SCREW 3.5 X [TAB] ORTHOLOC 3DSI

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    15
    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
    K113014

    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
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    145361 - 145369 LOCKING CORT SCREW 3.5 X [TAB] ORTHOLOC 3DSI 145360 - 145369 LOCKING CORT SCREW 3.5 X [TAB] ORTHOLOC 3DSI 40233532, 34, 36, 38, 40, 45, 50, 55, 60 LOCKING CORT SCREW 3.5 X [TAB] ORTHOLOC 3DSI 145370 - 145389 LOCKING CANC SCREW 3.5 X [TAB] ORTHOLOC 3DSI 145401 - 145407 LOCKING CORT SCREW 2.7 X [TAB] ORTHOLOC 3DSI 40223510, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 LOCKING CANC SCREW 3.5 X [TAB] ORTHOLOC 3DSI CLAW™ II STAR 10 DRIVER (40251100) 40232710, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 LOCKING CORT SCREW 2.7 X [TAB] ORTHOLOC 3DSI 40223532, 34, 36, 38, 40, 45, 50, 55 LOCKING CANC SCREW 3.5 X [TAB] ORTHOLOC 3DSI 145390 LOCKING CORT SCREW 3.5 X [TAB] ORTHOLOC 3DSI 145350 - 145360 LOCKING CORT SCREW 3.5 X [TAB] ORTHOLOC 3DSI 145390 - 145400 LOCKING CORT SCREW 2.7 X [TAB] ORTHOLOC 3DSI 40233510, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 LOCKING CORT SCREW 3.5 X [TAB] ORTHOLOC 3DSI 403S2710, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 LOCKING CANC SCREW 2.7 X [TAB] ORTHOLOC 3DSI 40232732, 34, 36, 38, 40, 45, 50 LOCKING CORT SCREW 2.7 X [TAB] ORTHOLOC 3DSI

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)