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

    Idys® C ZP 3DTi

    K Number: K240715 · Decision Mar 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    161
    Applicant Total
    10
    Review Days
    7

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    Basic Information

    Device Name
    Idys® C ZP 3DTi
    K Number
    K240715
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clariance
    Date Received
    March 15, 2024
    Decision Date
    March 22, 2024
    Product Code
    OVE
    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
    OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

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    Other Clearances by Clariance

    K Number Device Name
    K243904 Elegance® Anterior Cervical plate
    K243670 Idys® LIF
    K241863 Erisma® Lp Spinal Fixation System; Erisma® LP MIS
    K240872 Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
    K220182 Aggeris™-C
    K200919 Idys ALIF 3DTi
    K130853 IDYS(TM) C
    K131178 IDYS LIF CAGES
    K120469 ERISMA-LP