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    K Number
    K131834
    Device Name
    WOLF LONG BONE PLATE SYSTEM
    Manufacturer
    TOBY ORTHOPAEDICS
    Date Cleared
    2013-11-04

    (137 days)

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

    TOBY ORTHOPAEDICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The WOLF® Long Bone Plate system is indicated for fractures, osteotomies, and non-unions of upper extremity diaphyses.
    Device Description
    The TOBY® WOLF® Long Bone Plate system consists of implantable titanium alloy bone plates and fasteners used for the repair of fractures, osteotomies, and non-unions of upper extremity diaphyses. The system includes specialized stainless steel instrumentation that is provided to assist with the installation of the bone plates and fasteners.
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