BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    BI-MENTUM dual mobility system

    K Number: K181744 · Decision Dec 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    4
    Review Days
    162

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    Basic Information

    Device Name
    BI-MENTUM dual mobility system
    K Number
    K181744
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Serf
    Date Received
    July 2, 2018
    Decision Date
    December 11, 2018
    Product Code
    LZO
    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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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    Other Clearances by Serf

    K Number Device Name
    K223745 Novae® Dual Mobility System, Hype® Hip System
    K142675 CI../..X liner for NOVAE Dual Mobility Acetabular Cup
    K111572 NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL