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

    Erisma-LP Spinal Fixation System

    K Number: K153326 · Decision Mar 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    11
    Review Days
    110

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    Basic Information

    Device Name
    Erisma-LP Spinal Fixation System
    K Number
    K153326
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clariance, Sas
    Date Received
    November 19, 2015
    Decision Date
    March 8, 2016
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    Other Clearances by Clariance, Sas

    K Number Device Name
    K202032 Idys LLIF 3DTi
    K202956 Erisma LP Navigated Instruments
    K200920 Idys ALIF ZP 3DTi
    K192168 Idys ALIF ZP 3DTi
    K191263 Idys ALIF TiVac
    K183259 Idys™ TLIF TiVac
    K172465 Idys™ TLIF 3DTi Cages
    K172083 Idys™ ALIF System
    K170163 Erisma® LP Spinal Fixation System
    K162367 Erisma® LP MIS
    Search all 11 clearances from Clariance, Sas →