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510(k) Data Aggregation

    K Number
    K001339
    Device Name
    MRI FASTSYSTEM RETRACTOR SYSTEM
    Manufacturer
    OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.
    Date Cleared
    2000-05-17

    (20 days)

    Product Code
    GAD
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992583
    Device Name
    MASS (MICRO-ACCESS SPINE SYSTEM)
    Manufacturer
    OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.
    Date Cleared
    1999-10-29

    (88 days)

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

    OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use is for spinal surgery that is consistent with the working dimensions of the retractor/access port.
    Device Description
    The device a manually adjusted retractor system. It has a single- piece retractor/access port, fiber optic light cable accessory, 2 sets of 4 varying-sized dilators and assorted manual surgical instruments whose handles conform to the shape of the retractor/access port.
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