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

    PINNACLE CONSTRAINED ACETABULAR LINERS

    K Number: K043058 · Decision Mar 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    156
    Registration Numbers
    156
    Same Product Code
    33
    Applicant Total
    303
    Review Days
    129

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    Basic Information

    Device Name
    PINNACLE CONSTRAINED ACETABULAR LINERS
    K Number
    K043058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3310
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy, Inc.
    Date Received
    November 5, 2004
    Decision Date
    March 14, 2005
    Product Code
    KWZ
    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
    KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

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