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510(k) Data Aggregation

    K Number
    K241357
    Device Name
    XT3 System
    Manufacturer
    Biodynamik, Inc.
    Date Cleared
    2025-01-22

    (253 days)

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

    Biodynamik, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioDynamik XT3 System is indicated for fracture fixation and bone transport of the tibia in adults.
    Device Description
    The XT3 System is composed of the XT3 fixator, Half Pins, and instrumentation, which includes a Spacer, a Drill and Cut Guide, and drivers. The XT3 Fixator and instruments are single-use devices and are supplied non-sterile intended to be steam sterilized prior to use. The Half Pins are provided sterile by gamma irradiation and are for single use only. The XT3 fixator can be adjusted via an incorporated lifting plate to provide fracture fixation or bone transport.
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