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

    FUTURA TEXTURE-TRAKKED TOTAL HIP STEM

    K Number: K921382 · Decision Jan 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    655

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    Basic Information

    Device Name
    FUTURA TEXTURE-TRAKKED TOTAL HIP STEM
    K Number
    K921382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Arthronics, Inc.
    Date Received
    March 23, 1992
    Decision Date
    January 7, 1994
    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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