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

    Q SYSTEM 28 HIP STEM

    K Number: K910010 · Decision Mar 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    80
    Applicant Total
    26
    Review Days
    69

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    Basic Information

    Device Name
    Q SYSTEM 28 HIP STEM
    K Number
    K910010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Turnkey Intergration USA, Inc.
    Date Received
    January 2, 1991
    Decision Date
    March 12, 1991
    Product Code
    LWJ
    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
    LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

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