BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    SMR Finned Short Stems

    K Number: K191963 · Decision Oct 10, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    34
    Applicant Total
    8
    Review Days
    79

    Basic Information

    Device Name
    SMR Finned Short Stems
    K Number
    K191963
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3670
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LimaCorporate S.p.A
    Date Received
    July 23, 2019
    Decision Date
    October 10, 2019
    Product Code
    MBF
    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
    MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

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