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    K Number
    K113570
    Device Name
    INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP
    Manufacturer
    INTEGRA BURLINGTON MA, INC.
    Date Cleared
    2012-02-22

    (82 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA BURLINGTON MA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integra CUSA NXT Inferior Forward Bone Tip is an accessory to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
    Device Description
    The Integra CUSA NXT Inferior Forward Bone Tip (Inferior Forward Bone Tip) will attach to the Selector 24 kHz Neuro Short Handpiece (1523000M7) and will be controlled by the CUSA NXT Ultrasonic Surgical Aspirator System (CUSA NXT System). The CUSA NXT System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. The device allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The system consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a single use tip, and a suction/irrigation system (manifold tubing and cooling water canister). The Inferior Forward Bone Tip has an abrasive surface that is oriented inferiorly and distally at the distal end of the tip. This configuration facilitates the use of the system in procedures where it is necessary for practitioners to orient the surgical tip in the bottom dead center or inferior orientation. The Inferior Forward Bone Tip consists of a titanium tip with a titanium nitride coating, silicone flue and an ultem shroud. The Inferior Forward Bone Tip will be supplied sterile and is intended for single use.
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    K Number
    K111741
    Device Name
    INTEGRA(TM) CUSA NXT(TM) BONE TIPS
    Manufacturer
    INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI
    Date Cleared
    2011-08-23

    (63 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery. The indications for use for the NXT system have not changed due to the addition of the NXT Bone Tips.
    Device Description
    The NXT Bone tips will attach to the Selector 24 kHz Neuro Short Handpiece (1523000M7) and will be controlled by the CUSA NXT console. Ultrasonic surgical aspirators facilitate the removal of cellular and other unwanted soft and hard (e.g. bone) tissue. These systems provide selective tissue disintegration with simultaneous irrigation and aspiration. The modification is intended to provide improved visualization due to the protruded abrasive cutting surface, concomitant with improved relief geometry to enable fine and precise shaving or cutting when fragmenting, emulsifying and aspirating hard tissue. There are two NXT Bone Tips. The Superior Forward Bone Tip has an abrasive surface that is oriented superiorly and distally at the distal end of the tip. The Superior Reverse Bone Tip has an abrasive surface that is oriented superiorly and proximally at the distal end of the tip. The NXT Bone Tips consist of a titanium tip with a titanium nitride coating, silicone flue and an ultem shroud. The NXT Bone Tips will be supplied sterile and are intended for single use.
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