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510(k) Data Aggregation

    K Number
    K192465
    Device Name
    DigiFix Sterile Kit
    Manufacturer
    Virak Orthopedics, LLC
    Date Cleared
    2019-10-10

    (31 days)

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

    Virak Orthopedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIGIFIXTM External Fixation System is intended to be used in skeletally mature patients in treatment of: DYNAMIC MODE: 1) complex fracture-dislocations or fracture-subluxations, and pilon fractures of the interphalangeal (IP) joint; 2) Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint; 3) Dupuytren's contracture STATIC MODE: 1) Fractures of the phalanges and 2) interphalangeal (IP) joint arthrodesis.
    Device Description
    The DigiFix TM External Fixation System Sterile Kit includes various elements including brackets, locking pins, set screws and k-wires. The elements are used to create an assembled frame which capture and support the k-wires on the medial and lateral aspect of finger. The brackets, locking pins and set screws are assembled intraoperatively. External fixator components are provided sterile and are intended for single use only.
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