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510(k) Data Aggregation

    K Number
    K112675
    Device Name
    ARROW-LOK DIGITAL SYSTEM
    Manufacturer
    ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC
    Date Cleared
    2011-12-12

    (89 days)

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

    ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARROW-LOK Digital Fusion System is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.
    Device Description
    The ARROW-LOK Digital Fusion device features a three dimensional arrow shape. The implants are available in multiple lengths with arrowheads of various diameters and in 2 different angles. The implant is manufactured from stainless steel and is designed for single use only.
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