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

    UNIVATION

    K Number: K131167 · Decision Oct 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    90
    Applicant Total
    22
    Review Days
    176

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    Basic Information

    Device Name
    UNIVATION
    K Number
    K131167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap Implant Systems, LLC
    Date Received
    April 24, 2013
    Decision Date
    October 17, 2013
    Product Code
    HRY
    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
    HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

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