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510(k) Data Aggregation

    K Number
    K112658
    Device Name
    OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM
    Date Cleared
    2011-12-12

    (90 days)

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

    OSTEOSPRING MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OsteoSpring FootJack™ Subtalar Implant System is indicated for use in the treatment of hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limited excessive pronation and resulting sequela. The OsteoSpring FootJack Implant System . implants are intended for single patient use only.
    Device Description
    The OsteoSpring FootJack™ subtalar implant is intended to be implanted into the sinus tarsi of the foot. It will be available in a range of sizes. The implant is a solid, one-piece, conical, thread shaped and cannulated design.
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