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510(k) Data Aggregation

    K Number
    K142478
    Device Name
    opti-Toe
    Manufacturer
    Graham Medical Technologies, L.L.C. (d.b.a.GraMedica)
    Date Cleared
    2015-05-29

    (268 days)

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

    Graham Medical Technologies, L.L.C. (d.b.a.GraMedica)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GraMedica opti-Toe Device is indicated for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect their weight-bearing only until soft tissue healing has occurred.
    Device Description
    The GraMedica opti-Toe is comprised of two mated components (proximal and middle phalangeal) which join together to form a single intramedullary fixation unit. The implants are offered in two sizes, small and large, and the middle phalangeal component is offered with and without a 10 degree angulation.
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