BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    BiMobile Dual Mobility System - E-Dur Inserts

    K Number: K190535 · Decision Aug 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    42
    Review Days
    155

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    Basic Information

    Device Name
    BiMobile Dual Mobility System - E-Dur Inserts
    K Number
    K190535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Waldemar Link GmbH & Co. KG
    Date Received
    March 4, 2019
    Decision Date
    August 6, 2019
    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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