BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    Attune Revision LPS Inserts

    K Number: K191779 · Decision Oct 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    13
    Review Days
    98

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    Basic Information

    Device Name
    Attune Revision LPS Inserts
    K Number
    K191779
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy(Ireland)
    Date Received
    July 2, 2019
    Decision Date
    October 8, 2019
    Product Code
    KRO
    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
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

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    Other Clearances by Depuy(Ireland)

    K Number Device Name
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    K192448 Delta Xtend Revers Shoulder System
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    K170806 ATTUNE Cemented Tibial Base, Fixed Bearing
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    K160700 ATTUNE Revision Knee System
    K140881 DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
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