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

    COFIED MODULAR SHOULDER SYSTEM

    K Number: K955767 · Decision Apr 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    189
    Applicant Total
    87
    Review Days
    109

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    Basic Information

    Device Name
    COFIED MODULAR SHOULDER SYSTEM
    K Number
    K955767
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Smith & Nephew Richards, Inc.
    Date Received
    December 21, 1995
    Decision Date
    April 8, 1996
    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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