BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS

    K Number: K130533 · Decision May 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    67
    Applicant Total
    20
    Review Days
    77

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    Basic Information

    Device Name
    SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
    K Number
    K130533
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3110
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tornier S.A.S.
    Date Received
    March 1, 2013
    Decision Date
    May 17, 2013
    Product Code
    HSN
    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
    HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

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