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510(k) Data Aggregation

    K Number
    K062413
    Device Name
    AESCULAP PNEUMATIC KERRISON
    Manufacturer
    Date Cleared
    2006-11-21

    (96 days)

    Product Code
    Regulation Number
    882.4845
    Why did this record match?
    Product Code :

    HAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aesculap's Pneumatic Kerrison is intended for removing bone, cartilage and tissue in various surgical disciplines (e.g. neurosurgery and othopaedics).
    Device Description
    The Aesculap Pneumatic Kerrison is powered by pneumatic pressure. The power is supplied by compressed air through luer lock connectors. The compressed air is then transferred into the working direction via an angle lever. The movable sheath pusher moves forward and the punching action is carried out in a two step process.
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    K Number
    K022907
    Device Name
    ANSPACH POWERED KERRISON SYSTEM (PKS)
    Date Cleared
    2002-10-21

    (48 days)

    Product Code
    Regulation Number
    882.4845
    Why did this record match?
    Product Code :

    HAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Anspach Powered Kerrison System" (PKS) is indicated for use as an accessory attachment for I he rulisplay of the systems for cutting, shaping and removal of bone, including bones of the skull and spine.
    Device Description
    The Anspach PKS is designed to be operated by either pneumatic or electric power but without the forceful, rapid forward stroke of a stationary blade in other powered rongeur systems. The Anspach PKS removes bone using a high speed rotational (85k max. rpm) cutting blade advanced by an operator controlled trigger mechanism. PKS consists of four basic component parts: Pistol Grip Trigger Assembly housing, Straight Nose-Tube Attachment, Shielded Attachments, Cutters.
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