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510(k) Data Aggregation

    K Number
    K162507
    Device Name
    Arzzt 3.5 / 4.5 Small & Large Fragments System
    Manufacturer
    Date Cleared
    2017-08-03

    (329 days)

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

    TRUEMED GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Arzzt 3.5/4.5 Small & Large Fragment Systems is indicated for fixation of fractures, and nonunions of the humerus, radius, ulna, femur, and tibia.
    Device Description
    The Arzzt 3.5/4.5 Small & Large Fragments System consist of a variety of plates designed for specific bone areas, with orifices to receive either locking or non-locking screws. The screws are can be total or partially threaded and cannulated or not, some are self-tapping and they can be with or without locking features. All plates and screws may be manufactured in either stainless steel or titanium.
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    K Number
    K133166
    Device Name
    INS HILDEN TIBIAL ARZZT
    Manufacturer
    Date Cleared
    2014-11-06

    (385 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUEMED GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ins Hilden Tibial Arzzt is intended to stabilize fractures of the tibial shaft; open and closed tibial shaft fractures; and tibial malunion and non-unions.
    Device Description
    The Ins Hilden Tibial Arzzt is a single use system that consist the following components: - The Tibial Nail: a solid nail, with four orifices, two for distal locking and two for the proximal . locking. One of the orifices on the proximal locking is for static locking and one for dynamic locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole. - Locking Screws with conical head and self-tapping on the head and blunt. - End caps.
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