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510(k) Data Aggregation

    K Number
    K172205
    Device Name
    ExoToe Staple
    Manufacturer
    Date Cleared
    2018-01-11

    (174 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    ExoToe LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ExoToe Staple is intended for fracture and osteotomy fixation and joint arthrodesis of the foot in conjunction with k-wire fixation.
    Device Description
    The ExoToe Staple is an implant that is crimped onto bone with forceps after a k-wire has been placed to achieve fixation. The ExoToe Staple is provided in a sterile package. A kit containing four sizing templates and forceps is provided non-sterile. The staple is comprised of stainless steel and is pre-formed during manufacturing. The sizing templates and pliers are comprised of stainless steel. The sizing templates are used to select staple size. The forceps are used by a surgeon to conduct the final deformation required to anchor the staple to the bone.
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