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510(k) Data Aggregation

    K Number
    K152734
    Device Name
    Kerrison Rongeurs
    Date Cleared
    2016-06-18

    (270 days)

    Product Code
    Regulation Number
    882.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALITEC MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Vitalitec Kerrison Rongeurs are manually operated reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
    Device Description
    The Vitalitec Medizintechnik GmbH Kerrison Rongeurs are reusable stainless steel instruments that are sterilizable and packaged non-sterile. Devices are available with the following features: 1-6 mm bite sizes; 14 mm - 16 mm jaw openings; 40° and 90° up/down cutting angles; regular and thin footplates; various handle and shaft styles; sliding shaft; detachable. A rongeur is a robust constructed reusable surgical instrument with sharp, spoon shaped working ends, which used for cutting or biting bone during surgery involving the skull or spinal column.In Neurosurgery a rongeur is used for grasping and dissecting of bone and tissue during neurosurgical and orthopedic procedures.
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