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    FDA Registration Active 🇲🇾 Malaysia

    TAFN Nails Dia 10mm x 400mm Left (TAFN-100400L)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    63
    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
    K181184

    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
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    TAFN Nails Dia 10mm x 400mm Left (TAFN-100400L) TAFN Nail Size 10mm x 440mm Right TAFN-100440R TAFN Nail Size 13mm x 360mm Left (TAFN-130360L) TAFN Nail Size 11.5mm x 420mm Left (TAFN-115420L) TAFN Nail Size 13mm x 320mm Right (TAFN-130320R) TAFN Nail Size 10mm x 420mm Left (TAFN-100420L) TAFN Nail Size 13mm x 340mm Left (TAFN-130340L) TAFN Nail Size 11.5mm x 320mm Right (TAFN-115320R) TAFN Nail Size 13mm x 360mm Right TAFN-130360R TAFN Nail Size 11.5mm x 440mm Left (TAFN-115440L) TAFN Nail Size 11.5mm x 360mm Left (TAFN-115360L) TAFN Nail Size 11.5mm x 420mm Right TAFN-115420R TAFN Nail Size 10mm x 340mm Right TAFN-100340R TAFN Nail Size 11.5mm x 400mm Right TAFN-115400R TAFN Nail Size 11.5mm x 300mm Right (TAFN-115300R) TAFN Nail Size 10mm x 320mm Left (TAFN-100320L) TAFN Nail Size 10mm x 340mm Left (TAFN-100340L) TAFN Nail Size 11.5mm x 380mm Left (TAFN-115380L) TAFN Nail Size 11.5mm x 400mm Left (TAFN-115400L) TAFN Nail Size 13mm x 440mm Left (TAFN-130440L) TAFN Nail Size 10mm x 300mm Right (TAFN-100300R) TAFN Nail Size 10mm x 400mm Right TAFN-100400R TAFN Nail Size 11.5mm x 340mm Right TAFN-115340R TAFN Nail Size 13mm x 420mm Left (TAFN-130420L) TAFN Nail Size 13mm x 320mm Left (TAFN-130320L) TAFN Nail Size 13mm x 300mm Right (TAFN-130300R) TAFN Nail Size 11.5mm x 320mm Left (TAFN-115320L) TAFN Nail Size 11.5mm x 360mm Right TAFN-115360R TAFN Nail Size 10mm x 360mm Right TAFN-100360R TAFN Nail Size 10mm x 360mm Left (TAFN-100360L) TAFN Nail Size 11.5mm x 440mm Right TAFN-115440R TAFN Nail Size 13mm x 440mm Right TAFN-130440R TAFN Nail Size 13mm x 380mm Left (TAFN-130380L) TAFN Nail Size 13mm x 380mm Right TAFN-130380R TAFN Nail Size 10mm x 380mm Right TAFN-100380R TAFN Nail Size 10mm x 440mm Left (TAFN-100440L) TAFN Nail Size 10mm x 380mm Left (TAFN-100380L) TAFN Nail Size 11.5mm x 380mm Right TAFN-115380R TAFN Nail Size 13mm x 400mm Right TAFN-130400R TAFN Nail Size 13mm x 400mm Left (TAFN-130400L) TAFN Nail Size 13mm x 340mm Right TAFN-130340R TAFN Nail Size 10mm x 420mm Right TAFN-100420R TAFN Nail Size 10mm x 320mm Right (TAFN-100320R) TAFN Nail Size 11.5mm x 340mm Left (TAFN-115340L) TAFN Nail Size 13mm x 420mm Right TAFN-130420R 01-IM10 9.5mm Reamer Heads T10 Cannulated Driver (01-IMS02) Set Screw Driver Assembly (01-IM47) Lag Screw Inserter (01-IM44) Nail Length Gauge Assembly (01-IM02) 3.5mm Long Screw Driver (01-IM37) Handle Bolt Assembly(01-IM25 ) Tissue Protector Sleeve (01-IM32) Lag Screw Drill Sleeve Assembly (01-IM41) Hip /Femur Nail Extraction Bolt (01-IM57) Spindle, Handle Bolt Assembly (01-IM25-1) 12.5mm Tissue Protector Assembly (01-IM04) IM Screw Depth Gauge (01-IMS01) Lag Screw Reamer Assembly (01-IM43) 01-IM50 (3.5 MM HEX DRIVER SHAFT A/O QUICK CONNECT, 85 MM) Short Hip Nail 127.5 Degree, 11mm x 180mm (HIP127-110180) HIP NAIL PROXIMAL REAMER 16 MM (01-IM05) Handle, Handle Bolt Assembly (01-IM25-2)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)