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

    AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT

    K Number: K041160 · Decision May 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    26
    Applicant Total
    288
    Review Days
    24

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    Basic Information

    Device Name
    AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT
    K Number
    K041160
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp.
    Date Received
    May 3, 2004
    Decision Date
    May 27, 2004
    Product Code
    KRR
    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
    KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

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    K130895 REUNION RSA SHOULDER SYSTEM
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    K122853 NOVEL FIT AND FILL STEM
    K121315 STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
    K121308 HIP SYSTEMS
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