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

    CONSENSUS CS2 PLUS ACETABULAR INSERT

    K Number: K100933 · Decision Oct 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    271
    Registration Numbers
    271
    Same Product Code
    551
    Applicant Total
    7
    Review Days
    184

    Basic Information

    Device Name
    CONSENSUS CS2 PLUS ACETABULAR INSERT
    K Number
    K100933
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Consensus Orthopedics, Inc
    Date Received
    April 5, 2010
    Decision Date
    October 6, 2010
    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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