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

    ELIBRA SOFT-TISSUE FORCE SENSOR

    K Number: K132104 · Decision Mar 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    256

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    Basic Information

    Device Name
    ELIBRA SOFT-TISSUE FORCE SENSOR
    K Number
    K132104
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kamm & Associates
    Date Received
    July 8, 2013
    Decision Date
    March 21, 2014
    Product Code
    ONN
    Advisory Committee
    Neurology
    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
    ONN Intraoperative Orthopedic Joint Assessment Aid

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