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

    3M MODULAR SHOULDER SYSTEM

    K Number: K920362 · Decision Jul 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    189
    Applicant Total
    49
    Review Days
    541

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    Basic Information

    Device Name
    3M MODULAR SHOULDER SYSTEM
    K Number
    K920362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    3M Health Care, Ltd.
    Date Received
    January 28, 1992
    Decision Date
    July 22, 1993
    Product Code
    KWS
    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
    KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

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