BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇫🇷 France

    Tornier Pyrocarbon Humeral Head

    K Number: DEN220012 · Decision Dec 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    20
    Review Days
    311

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    Basic Information

    Device Name
    Tornier Pyrocarbon Humeral Head
    K Number
    DEN220012
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    888.3695
    Medical Specialty
    Orthopedic
    Decision
    Unknown
    Applicant
    Tornier S.A.S.
    Date Received
    February 8, 2022
    Decision Date
    December 16, 2022
    Product Code
    QKW
    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
    QKW Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

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