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

    COFIELD SHOULDER SYSTEM

    K Number: K855183 · Decision Mar 26, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    189
    Applicant Total
    71
    Review Days
    90

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    Basic Information

    Device Name
    COFIELD SHOULDER SYSTEM
    K Number
    K855183
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Richards Medical Co., Inc.
    Date Received
    December 26, 1985
    Decision Date
    March 26, 1986
    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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