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    FDA Registration Active 🇲🇾 Malaysia

    Maxlock Extreme 3.5mm Non-Locking Screw(35mm) (MFT-011-35-35)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Straits Orthopaedics (MFG) Sdn Bhd
    Registration Number
    3004889950
    FEI Number
    3004889950
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2, Lengkok Teluk Kumbar 1, Jalan Teluk Kumbar
    City
    Bayan Lepas Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K073624

    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

    Maxlock Extreme 3.5mm Non-Locking Screw(35mm) (MFT-011-35-35) Maxlock Extreme 3.5mm Fixed Angle Locking Screw(12mm) (MFT-021-35-12) Maxlock Extreme 2.7mm Non-Locking Screw (8mm) (MFT-011-27-08) Maxlock Extreme 3.5mm Non-Locking Screw(8mm) (MFT-011-35-08) MFT-011-35-425 (Diameter 3.5mm X 42.5mm Non-Locking Screw) Maxlock Extreme 3.5mm Fixed Angle Locking Screw(16mm) (MFT-021-35-16) MFT-011-35-22 (Diameter 3.5mm X 22mm Non-Locking Screw) MFT-011-35-375 (Diameter 3.5mm X 37.5mm Non-Locking Screw) MFT-021-35-18 (Diameter 3.5mm X 18mm Fixed Angle Locking Screw) MFT-011-40-30 (Diameter 4mm X 30mm Non-Locking Screw) MFT-011-40-325 (Diameter 4MM X 32.5MM NON-LOCKING SCREW) Maxlock Extreme 3.5mm Non-Locking Screw(18mm) (MFT-011-35-18) Maxlock Extreme 4mm Non-Locking Screw(8mm) (MFT-011-40-08) MFT-021-35-14 (Diameter 3.5MM X 14MM FIXED ANGLE LOCKING SCREW) Maxlock Extreme 3.5mm Non-Locking Screw(16mm) (MFT-011-35-16) Dia4MM X 26MM NON-LOCKING SCREW (MFT-011-40-26) MFT-011-40-40 (Diameter 4mm X 40mm Non-Locking Screw) MFT-011-40-35 (Diameter 4mm X 35mm Non-Locking Screw) (MFT-011-35-10) Diameter 3.5mm X 10mm Non-Locking Screw MFT-011-40-16 (Diameter 4MM X 16MM NON-LOCKING SCREW) Maxlock Extreme 3.5mm Fixed Angle Locking Screw(8mm) (MFT-021-35-08) MFT-011-40-45 (Diameter 4mm X 45mm Non-Locking Screw) MFT-011-40-20 (Diameter 4mm X 20mm Non-Locking Screw) MFT-011-40-12 (Diameter 4mm X 12mm Non-Locking Screw) MFT-021-35-24 (Diameter 3.5MM X 24MM FIXED ANGLE LOCKING SCREW) Dia3.5MM X 37.5MM FIXED ANGLE LOCKING SCREW (MFT-021-35-375) MFT-011-35-325 (Diameter 3.5mm X 32.5mm Non-Locking Screw) MFT-021-35-26 (Diameter 3.5mm X 26mm Fixed Angle Locking Screw) MFT-021-35-22 (Diameter 3.5mm X 22mm Fixed Angle Locking Screw) Maxlock Extreme 2.7mm Non-Locking Screw(16mm) (MFT-011-27-16) Maxlock Extreme 3.5mm Fixed Angle Locking Screw(28mm) (pMFT-021-35-28) MFT-011-35-40 (Diameter 3.5MM X 40MM NON-LOCKING SCREW) Maxlock Extreme 3.5mm Fixed Angle Locking Screw(28mm) (MFT-021-35-28) MFT-021-35-30 (Diameter 3.5MM X 30MM FIXED ANGLE LOCKING SCREW) Maxlock Extreme 3.5mm Non-Locking Screw(14mm) (MFT-011-35-14) Maxlock Extreme 3.5mm Fixed Angle Locking Screw(20mm) (MFT-021-35-20) MFT-011-35-28 (3.5mm x 28mm non-Locking Screw) Maxlock Extreme 4mm Non-Locking Screw (50mm) (MFT-011-40-60) MFT-011-35-08 (3.5mm x 8mm non-Locking Screw) MFT-011-27-20 (MFT 2.7mm x 20mm Non-Locking Screw)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)