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510(k) Data Aggregation

    K Number
    K181749
    Device Name
    SuperCable® Iso-Elastic™ Cerclage System
    Manufacturer
    Kinamed, Incorporated
    Date Cleared
    2018-08-01

    (30 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kinamed, Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kinamed SuperCable Iso-Elastic Cerclage System is intended to be used in the following: repair of long bone fractures due to trauma or reconstruction; reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy; sternotomy closure; and sublaminar and intrafacet wiring of the spinal column.
    Device Description
    The Kinamed SuperCable® Iso-Elastic™ Cerclage System consists of an implantable cable and locking clasp (the locking clasp consists of a clip and a wedge). The cable is comprised of a monofilament core of nylon with a jacket of ultra-high molecular-weight-polyethylene (UHMWPE) fibers braided around the nylon core. Manual instrumentation is used for applying the cable. The subject of the present Special 510(k) submission is a line addition of a cable implant whose locking clasp is manufactured using a metal injection molding (MIM) process.
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