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510(k) Data Aggregation

    K Number
    K990355
    Device Name
    STAINLESS STEEL SOFT SUTURE WIRE
    Manufacturer
    BREGMA INTERNATIONAL TRADING COMPANY LTD.
    Date Cleared
    1999-07-08

    (153 days)

    Product Code
    LRN
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREGMA INTERNATIONAL TRADING COMPANY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stainless Steel Soft Suture Wire is intended for general orthopedic surgery such as Sternulli Closure, nature bones and patella fracture fixation. The device is also intended for soft tissue approximation such as abdominal wound closure and hernia repair.
    Device Description
    Suture Wire (87 LRN)
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    K Number
    K990351
    Device Name
    BONE SCREWS
    Manufacturer
    BREGMA INTERNATIONAL TRADING COMPANY LTD.
    Date Cleared
    1999-06-01

    (116 days)

    Product Code
    HWC, JDW
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREGMA INTERNATIONAL TRADING COMPANY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bone screws are used to fix fractured long and short bones. They are also used to fasten bone plates. Bregma International manufactures three kinds of bonc screws, Aach with its own intended use. Cortical bone screws are used to augment compact and hard bones (diaphyseal reglons of the bones). Cancelluus bone screws are used in the epiphyseal and metaphyseal reglons of the bones which are largely soft and spongy. Cannulated bone screws, are used in situations where surgical wire is required to pass through the central axis of the screw, along which a holes has been drilled.
    Device Description
    Not Found
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    K Number
    K990353
    Device Name
    STAINLESS STEEL FIXATION PINS
    Manufacturer
    BREGMA INTERNATIONAL TRADING COMPANY LTD.
    Date Cleared
    1999-06-01

    (116 days)

    Product Code
    JDW, HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREGMA INTERNATIONAL TRADING COMPANY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kirschner Wire - ankle fracture fixation femoral shaft fracture hand fracture scaphold fracturc skeletal tractlon wrist fracture patellar fracture Steinman Pin - ankle arthrodesis tiblotibular syndesmosis fixallorı femoral shaft fracture acromloclavicular Jolnt repair skeletal traction
    Device Description
    Stainless Stool Fixation Pins
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