BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM

    K Number: K013428 · Decision Apr 4, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    19
    Review Days
    170

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    Basic Information

    Device Name
    MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
    K Number
    K013428
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ohio Medical Instrument Co., Inc.
    Date Received
    October 16, 2001
    Decision Date
    April 4, 2002
    Product Code
    HAW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HAW Neurological Stereotaxic Instrument

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    Other Clearances by Ohio Medical Instrument Co., Inc.

    K Number Device Name
    K021604 MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
    K992843 THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F
    K991267 SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A
    K983282 OMI OCCIPITAL CERVICAL LOOP, MODEL A1089
    K982244 MAYFIELD ACCISS OPTICAL SYSTEM
    K960807 TEW CRANIAL/SPINAL RETRACTOR MODEL A1090
    K953124 MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
    K941558 MAYFIELD CHILD DISPOSABLE SKULL PIN
    K934289 MAYFIELD RADIOLUCENT SKULL CLAMP
    K932807 MAYFIELD* A-2000 SKULL CLAMP
    Search all 19 clearances from Ohio Medical Instrument Co., Inc. →