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    K Number
    K230507
    Device Name
    Zimed Distal Medial Tibial Plate and Screw System
    Manufacturer
    Zimed Medikal
    Date Cleared
    2024-01-04

    (314 days)

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

    Zimed Medikal

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Zimed Distal Medial Tibial Plate and Screw System is indicated for fixation of complex extra-articular and intraarticular distal medial tibial fractures and osteotomies.
    Device Description
    Zimed Distal Medial Tibial Plate and Screw System is used for complex extra-articular and intraarticular distal tibial fractures, and osteotomies surgeries specifically designed for the anatomical alignment of the broken bones and to provide splinting with the ability to ensure the early mobility of the patient. Zimed plate and screw system is implantable device in long term contact with bones. Zimed Distal Medial Tibial Plate and Screw System will be supplied non-sterile.
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