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510(k) Data Aggregation

    K Number
    K972289
    Device Name
    MIDAS REX MOTOR
    Date Cleared
    1997-09-12

    (85 days)

    Product Code
    Regulation Number
    882.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDAS REX PNEUMATIC TOOLS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Midas Rex MRIV pneumatic motor provides power to operate an assortment of rotating surgical cutting tools. The motor is intended for skull based bone dissection and other microsurgical applications, including specialties in which a lightweight, high-speed bone dissecting system can be used in or near a magnetic field.
    Device Description
    The Midas Rex MRIV motor is an Ergonomically, designed lightweight variable speed motor, with a small overall diameter. The motor provides pneumatic power to operate removable attachments and rotating surgical dissecting tools. The motor operates at variable speeds on operating pressures range from 20-150 psi.
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    K Number
    K970965
    Device Name
    MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
    Date Cleared
    1997-04-09

    (23 days)

    Product Code
    Regulation Number
    874.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDAS REX PNEUMATIC TOOLS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Midas Rex III pneumatic motor is designed for used in Ear, Nose and Throat, Otolaryngology and Maxillofacial specifications.
    Device Description
    Ergonomically designed motor, 62 gram in weight, 15 mm in diameter with an overall length of approximately 10.25 centimeters. The Midas Rex III motor operates at variable speeds from 25 to 70 thousand rpm's. Operating pressures range from 20-150 psi (2-10 bar), with a suggested operating pressure of 100-psi (6.9 bar) and approximately 60 thousand rpm. The Midas Rex III has a standard quick disconnect GS dissecting tool and tube attachment system, which includes a fixed or rotating footed attachment, the telescoping micro systems, and the micro mini drill guide attachment.
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    K Number
    K962483
    Device Name
    MIDAS REX III MOTOR
    Date Cleared
    1996-11-19

    (146 days)

    Product Code
    Regulation Number
    882.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDAS REX PNEUMATIC TOOLS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Midas Rex Motor is designed for skull base and other microsurgical applications, including otolaryngology, ear, nose and throat, craniofacial and maxillofacial specifications in which a small, lightweight, high speed bone dissection system is desired.
    Device Description
    Ergonomically, designed lightweight motor featuring small, overall diameter for comfort and ease of handling. The Midas Rex III motor operates at variable speeds. Operating pressures range from 20-150 psi (2-10 bar), with a suggested operating pressure of 100 psi (6.9 bar). The Midas Rex III has a standard quick disconnect GS dissecting tool and tube attachment system, which includes a fixed or rotating footed attachment, the telescoping microsystems, and the micro mini drill guide.
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    K Number
    K953434
    Device Name
    MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
    Date Cleared
    1996-05-16

    (300 days)

    Product Code
    Regulation Number
    882.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDAS REX PNEUMATIC TOOLS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide power to operate removable rotating surgical cutting tools or drill bits on a patient's skull.
    Device Description
    The Midas Rex Motors (Midas I, Midas II and Convertible models) are air-powered, rotating motors designed to operate at 20-120 psi or at up to 200 psi. The motor is connected to an air-supply source by means of a stainless steel joint and a plastic air hose with inner rubber pressure hose. The motors are constructed of stainless steel, aluminum and brass and are designed to operate at 20-120 psi or at up to 200 psi with the same performance characteristics. Depending on user preference, the 200 psi motor is available in either a round or hexagonal casing, approximately 0.75 inch in diameter. Similarly, the 120 psi motor can be supplied in either a round or hexagonal casing in diameters of approximately 0.375, 0.5 or 0.75 inch. Again depending on user preference, the joint connecting the motor to the air hose can be equipped with a rotating cuff at one or both ends, allowing the motor and/or air hose to swivel independently with respect to the joint, thus providing greater freedom of movement during surgical procedures and avoiding possible "kinking" of the air hose. Thus, a variety of device configurations are possible based on the surgeon's personal preference, as shown below:
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