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

    ARCOMXL ACTIVE ARTICULATION

    K Number: K110555 · Decision Mar 24, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    93
    Review Days
    24

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    Basic Information

    Device Name
    ARCOMXL ACTIVE ARTICULATION
    K Number
    K110555
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Manufacturing Corp
    Date Received
    February 28, 2011
    Decision Date
    March 24, 2011
    Product Code
    LPH
    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
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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