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

    OSTEONICS SR GLENOID COMPONENTS

    K Number: K903886 · Decision Nov 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    189
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    OSTEONICS SR GLENOID COMPONENTS
    K Number
    K903886
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Osteonics Reconstructive Products Div.
    Date Received
    August 22, 1990
    Decision Date
    November 20, 1990
    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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    Other Clearances by Osteonics Reconstructive Products Div.

    K Number Device Name
    K895378 PROXIMAL CEMENT SPACER