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

    PRESS-FIT HEAD RESURFACING DEVICE

    K Number: K023188 · Decision Dec 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    22
    Applicant Total
    34
    Review Days
    78

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    Basic Information

    Device Name
    PRESS-FIT HEAD RESURFACING DEVICE
    K Number
    K023188
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3400
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Orthopedics, Inc.
    Date Received
    September 24, 2002
    Decision Date
    December 11, 2002
    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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    K030048 HA PMI FEMORAL HIP STEM
    K024086 PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
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    K023357 ARCPM 1050 RESIN-HIPS
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