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

    REFLECTION ACETABULAR REINFORCEMENT RINGS

    K Number: K962541 · Decision Sep 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    6
    Applicant Total
    87
    Review Days
    81

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    Basic Information

    Device Name
    REFLECTION ACETABULAR REINFORCEMENT RINGS
    K Number
    K962541
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Richards, Inc.
    Date Received
    June 28, 1996
    Decision Date
    September 17, 1996
    Product Code
    JDJ
    Advisory Committee
    General, Plastic Surgery
    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
    JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis

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