BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    ENCORE CLP OFFSET TOTAL HIP SYSTEM

    K Number: K052320 · Decision Dec 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    113
    Applicant Total
    1
    Review Days
    127

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    Basic Information

    Device Name
    ENCORE CLP OFFSET TOTAL HIP SYSTEM
    K Number
    K052320
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    888.3330
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Encore Medical Corporation
    Date Received
    August 25, 2005
    Decision Date
    December 30, 2005
    Product Code
    KWA
    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
    KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

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