BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PROMOS MODULAR SHOULDER SYSTEM

    K Number: K063578 · Decision Mar 2, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    70
    Applicant Total
    5
    Review Days
    92

    Basic Information

    Device Name
    PROMOS MODULAR SHOULDER SYSTEM
    K Number
    K063578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3690
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PLUS ORTHOPEDICS AG
    Date Received
    November 30, 2006
    Decision Date
    March 2, 2007
    Product Code
    HSD
    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
    HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

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