BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Small 115mm 5 Cable Troch Grip Trial (81005797, 71360030)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    37
    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
    K031162

    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
    Cerclage, Fixation JDQ

    Proprietary Names

    Small 115mm 5 Cable Troch Grip Trial (81005797, 71360030) Accord Low Profile Stainless Steel Plate Adaptor Screw (81010062, 71340015) Cable Plate Assembly 200mm (71346200) Standard 195mm 8 Cable Troch Grip Trial (71360035, 81005802) SS Cable Clamp Assembly (71340008) Small 75mm 3 Cable Troch Grip Trial (71360029, 81005796) Cable Clamp Assembly (71340007) Clamp Block (81005993) Accord Stainless Steel Button Plate Adaptor Sample (71370052) Plate W/Cable Clamps 250-3 (81007955) Standard 85mm 3 Cable Troch Grip Trial (71360033, 81005800) Accord Stainless Steel Button Plate Adaptor (81010059, 71340001) Cable (71340020) Cable Plate Assembly 250mm (71346250) Standard 11 Cable Troch Grip (71340013, 81029151) Small 185mm 8 Cable Troch Grip Trial (71360031, 81005798) Standard 125mm 5 Cable Troch Grip Trial (71360034, 81005801) Small 5 Cable Troch Grip (71340004, 81029145) Clamp Assembly Sample (71370007) Cable Clamp Body (81005984) 10-40 Screw Special Implant (81009372) Cable Plate Sample (71376150) SS Cable Clamp Body (81011570) Accord Stainless Steel Plate Adaptor Screw Sample (71370051) Small 8 Cable Troch Grip (71340005, 81029146) Cerlage Wire (1153448) Standard 3 Cable Troch Grip (71340010, 81029148) Standard 8 Cable Troch Grip (71340012, 81029150) Cable Plate Assembly 150mm (71346150) Small 11 Cable Troch Grip (81029147, 71340006) Small 255mm 11 Cable Troch Grip Trial (71360032, 81005799) Standard 5 Cable Troch Grip (71340011, 71370050, 81029149) Standard 265mm 11 Cable Troch Grip Trial (71360036, 81005803) SS Cable Clamp Top (81011569) Accord Low Profile Stainless Steel Button Plate Adaptor (81010061, 71340014) Cable Clamp Top (81005983) Small 3 Cable Troch Grip (81029144, 71340003)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)