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

    GLOBAL UNITE™ Platform Shoulder System

    K Number: K212710 · Decision Sep 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    203
    Applicant Total
    48
    Review Days
    20

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    Basic Information

    Device Name
    GLOBAL UNITE™ Platform Shoulder System
    K Number
    K212710
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Ireland UC
    Date Received
    August 26, 2021
    Decision Date
    September 15, 2021
    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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