BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)

    K Number: K173080 · Decision Oct 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    8
    Review Days
    32

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    Basic Information

    Device Name
    IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
    K Number
    K173080
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Huvexel Co. , Ltd.
    Date Received
    September 29, 2017
    Decision Date
    October 31, 2017
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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