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510(k) Data Aggregation

    K Number
    K083552
    Device Name
    MAXMORESPINE TOM STICK
    Manufacturer
    HOOGLAND SPINE PRODUCTS GMBH
    Date Cleared
    2009-10-09

    (312 days)

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

    HOOGLAND SPINE PRODUCTS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The maxMorespine Endoscope when used with recommended third party accessories/components, is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy and foraminotomy.
    Device Description
    The maxMorespine Endoscope is a rigid, multi-channel endoscope comprised of a working channel, rod lens optical system to transmit light and images with irrigation channel(s) and stopcocks. The body is designed of an outer and inner tube of surgical grade stainless steel. The proximal end of the endoscope; eyepiece and light post is adaptable to industry standard endoscopic camera and light systems. The endoscope will be introduced into the patient via a minimally invasive access through a working cannula with various instruments introduced through the Endoscope working channel (maxMorespine System submitted sepatately - K090132).
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    K Number
    K090132
    Device Name
    MAXMORESPINE SPINAL SYSTEM
    Manufacturer
    HOOGLAND SPINE PRODUCTS GMBH
    Date Cleared
    2009-06-09

    (139 days)

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

    HOOGLAND SPINE PRODUCTS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The maxMorespine System is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures such as: arthroplasty, nucleotomy, discectomy and foraminotomy.
    Device Description
    The maxMorespine System consists of basic cannulas, sheaths, dilators, drills, trephines, forceps, punches, mallet and quidewires which facilitate or compliment the maxMorespine Endoscope (submitted separately under K083552). The System is designed to provide the access and treatment of spinal anatomy and pathology.
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