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510(k) Data Aggregation

    K Number
    K993027
    Device Name
    ESKA MODULAR HIP SYSTEM
    Manufacturer
    SPECS USA, INC.
    Date Cleared
    2000-04-06

    (210 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESKA Modular Hip System is indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and post-traumatic arthritis, and the late stages of avascular necrosis, and for the revision of previous hip surgeries.
    Device Description
    The ESKA Modular Hip System is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems and heads, acetabular shells and modular liners, bipolar femoral heads, and bone screws. The femoral stems are anatomically designed in left and right configurations, with anteverted femoral necks. There are fully porous, proximally porous. collared and collarless options. The acetabular components are porous, with various liner options and screws for supplementary fixation. Pre-assembled bipolar and unipolar components are also available.
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    K Number
    K946349
    Device Name
    STENODOC
    Manufacturer
    SPECS USA, INC.
    Date Cleared
    1996-05-24

    (511 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Detection and analysis of vascular disease in peripheral vessels. Evaluation of degree and site of a stenosis. Detection of occlusions and flow disturbances. Determination of vessel type and location. Measurement of relative flow velocity. Not intended for fetal use.
    Device Description
    Stenodoc is a mains independent portable continuous wave Doppler ultrasound device with two pen-shaped split-D transducers operating at 4 MHz and 8 MHz. A 512 point fast Fourier transform (FFT) is performed on the returned signal. The spectral distribution of blood flow is represented as a frequency over time diagram with intensities represented by different shades of gray. The diagram is displayed on a liquid crystal display (LCD). Measurements can be annotated with the patient's name, vessel name and a diagnosis and can be stored on a built-in harddisk for later evaluation. Size: 3" x 13.5" x 10" (Height/Width/Depth) Weight: 9 lbs.
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