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

    EMPOWR Partial Knee

    K Number: K191325 · Decision Jul 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    113
    Applicant Total
    81
    Review Days
    61

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    Basic Information

    Device Name
    EMPOWR Partial Knee
    K Number
    K191325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Encore Medical L.P.
    Date Received
    May 16, 2019
    Decision Date
    July 16, 2019
    Product Code
    HSX
    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
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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