BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Lag Screw Inserter - Connecter (01-IM45)

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    85
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRAITS ORTHOPAEDICS (MFG) SDN BHD
    Registration Number
    3025603301
    FEI Number
    3025603301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1264, Lorong PSPN 1, Penang Science Park North
    City
    Simpang Ampat Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K150655

    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

    Lag Screw Inserter - Connecter (01-IM45) 14.5MM REAMER HEADS (01-IM20) 13MM REAMER HEADS (01-IM17) 11MM REAMER HEADS (01-IM13) 14MM REAMER HEADS (01-IM19) 9MM END CUTTING REAMER (01-IM09) 13.5MM REAMER HEADS (01-IM18) 12.5MM REAMER HEADS (01-IM16) 10MM REAMER HEADS (01-IM11) 9.5MM REAMER HEADS (01-IM10) Hip Nail 127.5 Degree, 11mm x 180mm Hip Nail 127.5 Degree, 11mm x 420mm Left (HIP127-110420L) Set Screw Hip Nail 127.5 Degree, 11mm x 340mm Left Hip Nail 127.5 Degree, 11mm x 400mm Right (HIP127-110400R) Gripper (Keyless T-Handle) Hip Nail 127.5 Degree, 11mm x 360mm Left (HIP127-110360L) Hip Nail 127.5 Degree, 11mm x 340mm Right Set Screw (HIPHSS-0915) Hip Nail 127.5 Degree, 11mm x 380mm Left Hip Nail 127.5 Degree, 11mm x 400mm Right Hip Nail 127.5 Degree, 11mm x 360mm Right Hip Nail 127.5 Degree, 11mm x 380mm Right (HIP127-110380R) AWL Lag Screw Depth Gauge Tibia Nail Size 9x320 (OC10724M) Hip Nail 127.5 Degree, 11mm x 380mm Right Hip Nail 127.5 Degree, 11mm x 420mm Left Lag Screw Driver - Connector Hip Nail 127.5 Degree, 11mm x 360mm Right (HIP127-110360R) Gripper (Keyless T-Handle)- 01-IM07 Hip Nail 127.5 Degree, 11mm x 340mm Left (HIP127-110340L) Nail Length Gauge (01-IM02) Nail Length Gauge Lag Screw Depth Gauge (01-IM42) Hip Nail 127.5 Degree, 11mm x 180mm (HIP127-110180) Hip Nail 127.5 Degree, 11mm x 360mm Left Ante / Retrograde Nail Size 10mm x 320mm (OC10441M) Hip Nail 127.5 Degree, 11mm x 400mm Left Hip Nail 127.5 Degree, 11mm x 420mm Right (HIP127-110420R) Lag Screw Driver - Connector (01-IM45) Distal Screw Length Gauge (01-IM35) AWL (01-IM01) Tibia Nail Size 10x320 (OC10725M) Distal Screw Length Gauge Hip Nail 127.5 Degree, 11mm x 380mm Left (HIP127-110380L) Hip Nail 127.5 Degree, 11mm x 400mm Left (HIP127-110400L) Tibia Nail Size 9x400 (OC10736M) Lag Screw Inserter Guide Bolt Ball Tip Screw Driver Tibia Nail Size 10x340 (OC10728M) Lag Screw Inserter (01-IM44) Guide Bolt Ball Tip Screw Driver (01-IM29) Tibia Nail Size 9x340 (OC10727M) Hip Nail 127.5 Degree, 11mm x 340mm Right (HIP127-110340R) 127.5 Degree HIP Nail, 11mm x 320mm Right (OC10905M) Tibia Nail Size 11.5x320 (OC10726M) Hip Nail 127.5 Degree, 11mm x 420mm Right Tibia Nail Size 10x300 (OC10722M) Ante / Retrograde Nail Size 13mm x 320mm (OC10443M) Ante / Retrograde Nail (OC10444M-OC10461M) Tibia Nail Size 11.5x400 (OC10738M) 32-400 - Calibrated Guide Pin 3.2mm x 400mm Tibia Nail Size 10x400 (OC10737M) Tibia Nail Size 9x300 (OC10721M) Tibia Nail Size 11.5x360 (OC10732M) Tibia Nail Size 11.5x300 (OC10723M) Tibia Nail Size 11.5x380 (OC10735M) Tibia Nail Size 11.5x420 (OC10741M) Ante / Retrograde Nail Size 11.5mm x 320mm (OC10442M) Tibia Nail Size 9x420 (OC10739M) Tibia Nail Size 10x360 (OC10731M) 127.5 Degree HIP Nail, 11mm x 320mm Left (OC10904M) Tibia Nail Size 11.5x340 (OC10729M) Tibia Nail Size 10x380 (OC10734M) Tibia Nail Size 9x380 (OC10733M) Tibia Nail Size 9x280 (OC10718M) Tibia Nail Size 9x360 (OC10730M) Tibia Nail Size 10x210mm (OC09009M) Hip Nail 127.5 Degree, 11mm x 440mm Left (HIP127-110440L) 127.5 Degree HIP Nail, 10mm X 180mm (HIP127-100180) Guide Pin Calibrated Diameter 3.2 x 400mm (32-400) 12MM REAMER HEADS (01-IM15) 10.5MM REAMER HEADS (01-IM12) 11.5MM REAMER HEADS (01-IM14)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)