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

    Erisma® Lp Spinal Fixation System; Erisma® LP MIS

    K Number: K241863 · Decision Jul 24, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    10
    Review Days
    27

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    Basic Information

    Device Name
    Erisma® Lp Spinal Fixation System; Erisma® LP MIS
    K Number
    K241863
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clariance
    Date Received
    June 27, 2024
    Decision Date
    July 24, 2024
    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

    K Number Device Name
    K243904 Elegance® Anterior Cervical plate
    K243670 Idys® LIF
    K240872 Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
    K240715 Idys® C ZP 3DTi
    K220182 Aggeris™-C
    K200919 Idys ALIF 3DTi
    K130853 IDYS(TM) C
    K131178 IDYS LIF CAGES
    K120469 ERISMA-LP