BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VERTEBRACE SPINAL SUPPORTS

    K Number: K791314 · Decision Jul 30, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    14

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    Basic Information

    Device Name
    VERTEBRACE SPINAL SUPPORTS
    K Number
    K791314
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3490
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Vertebrace, Inc.
    Date Received
    July 16, 1979
    Decision Date
    July 30, 1979
    Product Code
    IPY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IPY Orthosis, Lumbo-Sacral

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