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

    SIGMA High Performance (HP) Partial Knee System

    K Number: K193549 · Decision Apr 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    90
    Applicant Total
    48
    Review Days
    118

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    Basic Information

    Device Name
    SIGMA High Performance (HP) Partial Knee System
    K Number
    K193549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Ireland UC
    Date Received
    December 20, 2019
    Decision Date
    April 16, 2020
    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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