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    FDA Registration Active 🇲🇾 Malaysia

    SIDEKICK™ TRANSFIX PIN 5MM TIN 300MM W/ WIRE HOLE TIP (RR50300CTN)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    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
    K052005

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    SIDEKICK™ TRANSFIX PIN 5MM TIN 300MM W/ WIRE HOLE TIP (RR50300CTN) Threaded Rod, 150 mm (RR0150TR) Male Post, 2 Hole (RR20P) Bolt, 12 mm (RR1200) Transfixing Pin, 4mm x 300 mm (RR4000300) Bolt, 20 mm (RR2000) Threaded Rod, 165 mm (RR0165TR) Male Post, 4 Hole (RR40P) Threaded Rod, 120 mm (RR0120TR) Threaded Rod, 200 mm (RR0200TR) SIDEKICK™ HALF PIN 5X30 TIN (RR5030TN) Bolt, 16 mm (RR1600) Wire, Bayonet 1.8 mm x 400 mm (RR18400) Wire w/Stopper 1.8 mm x 400 mm (RR180400) Square Nut (RR1010) Male Post, 1 Hole (RR10P) SIDEKICK™ HALF PIN 5X25 TIN (RR5025TN) Slotted Washer (RR2101) Threaded Rod, 80 mm (RR0080TR) Nut, 10 mm (RR1001) Washer, 1mm (RR2401) Sidekick® Half Pin 5 x 35 Tin 180mm Long (RR5035TN) HALF PIN 4MMX180MM 40MM THREAD (RR4040)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)