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510(k) Data Aggregation

    K Number
    K100926
    Device Name
    ARROWHEAD FIXATION DEVICE
    Manufacturer
    ARROW PRODUCTS, INC.
    Date Cleared
    2010-10-29

    (207 days)

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

    ARROW PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arrowhead 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 Arrowhead Fixation Device implant features a three dimensional arrow shape. The implants are available in multiple lengths and in 2 different angles. The implant is manufactured from stainless steel and is designed for single use only.
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