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

    NEER TYPE SHOULDER PROSTHESIS SYSTEM

    K Number: K922865 · Decision Dec 10, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    70
    Applicant Total
    18
    Review Days
    189

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    Basic Information

    Device Name
    NEER TYPE SHOULDER PROSTHESIS SYSTEM
    K Number
    K922865
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3650
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Osteo Technology, Inc.
    Date Received
    June 4, 1992
    Decision Date
    December 10, 1992
    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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