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

    OMI OCCIPITAL CERVICAL LOOP, MODEL A1089

    K Number: K983282 · Decision Nov 19, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    19
    Review Days
    62

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    Basic Information

    Device Name
    OMI OCCIPITAL CERVICAL LOOP, MODEL A1089
    K Number
    K983282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ohio Medical Instrument Co., Inc.
    Date Received
    September 18, 1998
    Decision Date
    November 19, 1998
    Product Code
    KWP
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KWP Appliance, Fixation, Spinal Interlaminal

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