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    FDA Registration Active 🇲🇾 Malaysia

    Maxtorque Self-Drilling Cannulated 7 x 75mm Long Thread Screw (MSD-010-70-075L)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    62
    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
    K060428

    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
    Washer, Bolt Nut HTN

    Proprietary Names

    Maxtorque Self-Drilling Cannulated 7 x 75mm Long Thread Screw (MSD-010-70-075L) Maxtorque Self-Drilling Cannulated 5.5 x 55mm Long Thread Screw (MSD-010-55-055L) (MSD-010-55-425S) SELF DRILL CANNULA DIA 5.5MM X 42.5MM SHORT THREAD SCREW (MSD-010-55-055S) SELF DRILL CANNULA DIA 5.5MM X 55MM SHORT THREAD SCREW (MSD-010-70-130S) SELF DRILL CANNULA DIA 7MM X 130MM SHORT THREAD SCREW Maxtorque Self-Drilling Cannulated 7 x 95mm Long Thread Screw (MSD-010-70-095L) MSD-010-70-050S (Self Drill Cannula 7mm X 50mm Short Threaded Screw) Maxtorque Blunt Tip Cannulated 5.5 x 70mm Long Thread Screw (CSS-011-55-070L) Maxtorque Blunt Tip Cannulated 5.5 x 26mm Short Threaded Screw (CSS-011-55-026S) Maxtorque Self-Drilling Cannulated 7mm x 120mm Long Thread Screw (MSD-010-70-120L) (MSD-010-70-050L) SELF DRILL CANNULA DIA 7MM X 50MM LONG THREAD SCREW Maxtorque Self-Drilling Cannulated 7 x 100mm Long Thread Screw (MSD-010-70-100L) (MSD-010-40-375S) SELF DRILL CANNULA DIA 4MM X 37.5MM SHORT THREAD SCREW (MSD-010-40-325L) SELF DRILL CANNULA DIA 4MM X 32.5MM LONG THREAD SCREW MSD-010-70-055S (Self Drill Cannula 7mm X 55mm Short Threaded Screw) (MSD-010-70-065L) SELF DRILL CANNULA DIA 7MM X 65MM LONG THREAD SCREW (MSD-010-40-028L) Maxtorque Self-Drilling Cannulated 4 x 28mm Thread Screw Maxtorque Self-Drilling Cannulated 4mm x 42.5mm Short Thread Screw (MSD-010-40-425L) (MSD-010-70-105L) SELF DRILL CANNULA DIA 7MM X 105MM LONG THREAD SCREW (MSD-010-55-475S) SELF DRILL CANNULA DIA 5.5MM X 47.5MM SHORT THREAD SCREW Maxtorque Self-Drilling Cannulated 7mm x 125mm Short Thread Screw (MSD-010-70-125S) (MSD-010-40-060L) SELF DRILL CANNULA DIA 4MM X 60MM LONG THREAD SCREW Maxtorque Self-Drilling Cannulated 5.5mm x 30mm Short Thread Screw (MSD-010-55-030S) Maxtorque Blunt Tip Cannulated 5.5mm x 45mm Long Thread Screw (CSS-011-55-045L) SELF DRILL CANNULA DIA4MM X 40MM SHORT THREAD SCREW (MSD-010-40-040S) (MSD-010-70-105S) SELF DRILL CANNULA DIA 7MM X 105MM SHORT THREAD SCREW MSD-010-70-070S (Self Drill Cannula 7mm X 70mm Short Threaded Screw) (MSD-010-70-060S) SELF DRILL CANNULA DIA 7MM X 60MM SHORT THREAD SCREW (MSD-010-70-110L) SELF DRILL CANNULA DIA 7MM X 110MM LONG THREAD SCREW (MSD-010-55-070L) SELF DRILL CANNULA DIA 5.5MM X 70MM LONG THREAD SCREW Maxtorque Self-Drilling Cannulated 7 x 100mm Short Thread Screw (MSD-010-70-100S) Maxtorque Self-Drilling Cannulated 7mm x 47.5mm Short Thread Screw (MSD-010-70-475S) (MSD-010-70-055L) SELF DRILL CANNULA DIA 7MM X 55MM LONG THREAD SCREW Maxtorque Blunt Tip Cannulated 4mm x 16mm Short Thread Screw (CSS-011-40-016S) (MSD-010-70-130L) SELF DRILL CANNULA DIA 7MM X 130MM LONG THREAD SCREW (MSD-010-70-040S) SELF DRILL CANNULA DIA 7MM X 40MM SHORT THREAD SCREW Maxtorque Self-Drilling Cannulated 5.5mm X 28mm Short Thread Screw (MSD-010-55-028S) Maxtorque Self-Drilling Cannulated 7mm x 110mm Short Thread Screw (MSD-010-70-110S) Maxtorque Self-Drilling Cannulated 5.5mm x 50mm Long Thread Screw (MSD-010-55-050L) Maxtorque Blunt Tip Cannulated 4mm x 47.5mm Long Thread Screw (CSS-011-40-475L) (MSD-010-70-065P) SELF DRILL CANNULA DIA 7MM X 65MM PETITE THREAD SCREW Maxtorque Self-Drilling Cannulated 7mm x 95mm Short Thread Screw (MSD-010-70-095S) Maxtorque Self-Drilling Cannulated 7mm x 60mm Long Thread Screw (MSD-010-70-060L) Maxtorque Self-Drilling Cannulated 7mm x 115mm Long Thread Screw (MSD-010-70-115L) Maxtorque Self-Drilling Cannulated 7mm x 125mm Long Thread Screw (MSD-010-70-125L) Maxtorque Self-Drilling Cannulated 5.5mm x 95mm Short Thread Screw (MSD-010-55-095S) MSD-010-70-085L (Maxtorque Self-Drilling Cannulated 7 x 85mm Long Thread Screw) MSD-010-40-018S (Maxtorque Self-Drilling Cannulated 4 x 18mm Short Thread Screw) Maxtorque Self-Drilling Cannulated 5.5mm x 47.5mm Long Thread Screw (MSD-010-55-475L) Maxtorque Self-Drilling Cannulated 7mm x 80mm Long Thread Screw (MSD-010-70-080L) Maxtorque Self-Drilling Cannulated 7mm x 45mm Short Thread Screw (MSD-010-70-045S) Maxtorque Self-Drilling Cannulated 7mm x 65mm Long Thread Screw (MSD-010-70-065S) Maxtorque Self-Drilling Cannulated 7mm x 90mm Short Thread Screw (MSD-010-70-090S) Maxtorque Blunt Tip Cannulated 7mm x 115mm Long Thread Screw (CSS-011-70-115L) MSD-010-55-085S (Maxtorque Self-Drilling Cannulated 5.5 x 85mm Short Thread Screw) Maxtorque Self-Drilling Cannulated 7mm x 85mm Long Thread Screw (MSD-010-70-085L) MSD-010-70-125S (Maxtorque Self-Drilling Cannulated 7 x 125mm Short Thread Screw) MSD-010-70-115L (Maxtorque Self-Drilling Cannulated 7 x 115mm Long Thread Screw) MSD-010-70-060L (Maxtorque Self-Drilling Cannulated 7 x 60mm Long Thread Screw) CSS-011-40-030S (Blunt Tip Cannula 4mm x 30mm Short Thread Screw) MSD-010-70-090L (Maxtorque Self-Drilling Cannulated 7 x 90mm long Thread Screw) MSD-010-40-065L (Maxtorque Self-Drilling Cannulated 4 x 65mm Long Thread Screw)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)