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

    INTEGRITY SPINAL CARE SYSTEM 3.0

    K Number: K130249 · Decision Feb 6, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    70
    Applicant Total
    1
    Review Days
    370

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    Basic Information

    Device Name
    INTEGRITY SPINAL CARE SYSTEM 3.0
    K Number
    K130249
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integrity Life Sciences
    Date Received
    February 1, 2013
    Decision Date
    February 6, 2014
    Product Code
    ITH
    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
    ITH Equipment, Traction, Powered

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