BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    M2A/C2A ACETABULAR SYSTEM

    K Number: K042841 · Decision Dec 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    44
    Applicant Total
    441
    Review Days
    68

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    Basic Information

    Device Name
    M2A/C2A ACETABULAR SYSTEM
    K Number
    K042841
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    888.3320
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet, Inc.
    Date Received
    October 14, 2004
    Decision Date
    December 21, 2004
    Product Code
    JDL
    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
    JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

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