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

    NEER-III GLENOID RESURFACING PROSTHESIS

    K Number: K873104 · Decision Oct 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    68
    Applicant Total
    76
    Review Days
    69

    Basic Information

    Device Name
    NEER-III GLENOID RESURFACING PROSTHESIS
    K Number
    K873104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3650
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    KIRSCHNER MEDICAL CORP.
    Date Received
    August 7, 1987
    Decision Date
    October 15, 1987
    Product Code
    KWT
    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
    KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

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