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510(k) Data Aggregation

    K Number
    K070874
    Device Name
    ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR
    Manufacturer
    ARTHRO KINETICS INC.
    Date Cleared
    2007-11-02

    (218 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTHRO KINETICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in surgical procedures such as but not limited to orthopedic, arthroscopic, and spinal procedures.
    Device Description
    Not Found
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    K Number
    K061246
    Device Name
    ENDOSCOPIC SPINE SYSTEM
    Manufacturer
    ARTHRO KINETICS INC.
    Date Cleared
    2006-08-23

    (112 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTHRO KINETICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arthro Kinetics' Endoscopic Spine System (Kinetics Interchangeable Spine System) is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy.
    Device Description
    The Arthro Kinetics Endoscopic Spine System consists of an Endoscope, light source, light guide, sheaths, camera head, and camera control unit and is a reusable minimally invasive system that enables surgeons to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy. The outer sheath acts to facilitate suction / irrigation to the surgical site, serving as a cannula to provide an access portal for the endoscope to be inserted into the patient for viewing or the placing of manual surgical instruments. By inserting the endoscope into the outer sheath the surgeon will be able to view the operative site whilst being guided to the pain source by the ongoing feedback from the patient. The endoscope also has a working channel to allow surgical instruments to be inserted into the operative site.
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