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

    REFLECTION DUAL DIMENSION SHELL

    K Number: K960094 · Decision Mar 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    12
    Applicant Total
    87
    Review Days
    76

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    Basic Information

    Device Name
    REFLECTION DUAL DIMENSION SHELL
    K Number
    K960094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Richards, Inc.
    Date Received
    January 11, 1996
    Decision Date
    March 27, 1996
    Product Code
    MBL
    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
    MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

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