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

    RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD

    K Number: K071053 · Decision Jun 29, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    22
    Applicant Total
    441
    Review Days
    77

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    Basic Information

    Device Name
    RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
    K Number
    K071053
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3400
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet, Inc.
    Date Received
    April 13, 2007
    Decision Date
    June 29, 2007
    Product Code
    KXA
    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
    KXA Prosthesis, Hip, Femoral, Resurfacing

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