BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PEEK CAGE FOR THE VERTEBRAL SPINE

    K Number: K132852 · Decision May 29, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    5
    Review Days
    260

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    Basic Information

    Device Name
    PEEK CAGE FOR THE VERTEBRAL SPINE
    K Number
    K132852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neoortho Produtos Ortopedicos S/A
    Date Received
    September 11, 2013
    Decision Date
    May 29, 2014
    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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