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510(k) Data Aggregation

    K Number
    K140644
    Device Name
    PROCEM
    Manufacturer
    OTOTRONIX, LLC
    Date Cleared
    2014-06-19

    (98 days)

    Product Code
    NEA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTOTRONIX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProCem™ is intended for non-weight bearing applications in Otologic surgery, such as: 1. Reconstruction of ossicular bones or mechanical coupling of the ossicular chain. 2. Mechanical stabilization of middle ear and cochlear implants. 3. Attachment of middle ear implants to the ossicular bones.
    Device Description
    ProCem™ is glass ionomer cement that is provided as two components, a glass powder and polyacrylic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ. ProCem™ is provided in a sterile capsule. The capsule includes the two separate components, a glass powder and polyacrylic acid liquid. An activator is used to release the liquid component prior to use. The capsule is then placed in a mixer, which mixes the glass powder and polyacrylic acid liquid to form a compliant cement. The applicator is used to apply the compliant cement to the appropriate location in the middle ear. The cement then hardens in place to provide a permanent bond.
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    K Number
    K130201
    Device Name
    NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
    Manufacturer
    OTOTRONIX, LLC
    Date Cleared
    2013-04-26

    (88 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTOTRONIX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nystagram™ is a video nystagmograph intended to view, record, and measure eye movements in support of identification of balance disorders. The device is intended for use only by qualified, trained medical personnel to aid in diagnostic recommendations. This device does not provide any medical diagnosis and is intended to be part of a larger balance assessment battery.
    Device Description
    The Nystagram™ is a device that views, records and measures both vertical and horizontal eye movements for support of identification of balance disorders. The results of the video nystagmograph (VNG) tests are combined with other clinical information to allow qualified medical personnel to determine the health of a patient's vestibular function system. The Nystagram™ system consists of a goggles system with a video camera and accelerometers to record eye movements and head position, computer monitors and other hardware and software to control the operation of the patient stimulus and the test administration functions. The system software is used for nystagmus analysis during oculomotor mobility, positional nystagmus, and caloric examinations. The results are presented in visual diagrams for clinical review.
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