LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K132731
    Device Name
    DIGIFIX EXTERNAL FIXATION SYSTEM
    Manufacturer
    VIRAK ORTHOPEDIC RESEARCH, LLC
    Date Cleared
    2014-01-10

    (129 days)

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

    VIRAK ORTHOPEDIC RESEARCH, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIGIFIX™ External Fixation System is intended to be used in skeletally mature patients in treatment of: DYNAMIC MODE: 1) complex fracture-dislocations or fracture-subluxation, unstable dislocations, and pilon fractures of the interphalangeal (IP) joint; 2) Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint; STATIC MODE: 1) comminuted fractures of the phalanges and 2) interphalangeal (IP) joint arthrodesis.
    Device Description
    The DigiFix™ External Fixation System 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 non-sterile and are intended for single use only.
    Ask a Question

    Page 1 of 1