BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM

    K Number: K032641 · Decision Jan 20, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    158
    Applicant Total
    5
    Review Days
    146

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    Basic Information

    Device Name
    MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
    K Number
    K032641
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Portland Orthopaedics Pty. , Ltd.
    Date Received
    August 27, 2003
    Decision Date
    January 20, 2004
    Product Code
    MEH
    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
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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    Other Clearances by Portland Orthopaedics Pty. , Ltd.

    K Number Device Name
    K061564 PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
    K053417 M-COR HIP REPLACEMENT SYSTEM
    K051844 EQUATOR PLUS ACETABULAR CUP SYSTEM
    K992815 THE MARGRON HIP REPLACEMENT SYSTEM