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

    AEQUALIS REVERSED SHOULDER PROSTHESIS

    K Number: K081059 · Decision Jul 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    203
    Applicant Total
    44
    Review Days
    94

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    Basic Information

    Device Name
    AEQUALIS REVERSED SHOULDER PROSTHESIS
    K Number
    K081059
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tornier
    Date Received
    April 14, 2008
    Decision Date
    July 17, 2008
    Product Code
    PHX
    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
    PHX Shoulder Prosthesis, Reverse Configuration

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    Other Clearances by Tornier

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    K111970 KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
    K111902 AEQUALIS SHOULDER SYSTEM
    K094013 HLS KNEETEC SYSTEM
    K100142 AEQUALIS REVERSED SHOULDER PROSTHESIS
    K091870 TORNIER, PITON FIXATION IMPLANT SYSTEM
    K090076 SALTO TALARIS TOTAL ANKLE PROSTHESIS
    K082754 AEQUALIS HUMERAL NAIL SYSTEM
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