BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    LINK® Embrace Shoulder System - Reverse Configuration

    K Number: K212992 · Decision Nov 18, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    203
    Applicant Total
    42
    Review Days
    59

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    Basic Information

    Device Name
    LINK® Embrace Shoulder System - Reverse Configuration
    K Number
    K212992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Waldemar Link GmbH & Co. KG
    Date Received
    September 20, 2021
    Decision Date
    November 18, 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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