BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System

    K Number: K143134 · Decision Mar 5, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    71
    Applicant Total
    2
    Review Days
    125

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    Basic Information

    Device Name
    NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System
    K Number
    K143134
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cossington, Ltd.
    Date Received
    October 31, 2014
    Decision Date
    March 5, 2015
    Product Code
    LOD
    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
    LOD Bone Cement

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    Other Clearances by Cossington, Ltd.

    K Number Device Name
    K143100 NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta