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

    PARAMOUNT R IBF DEVICE

    K Number: K103228 · Decision Jan 5, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    23
    Review Days
    64

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    Basic Information

    Device Name
    PARAMOUNT R IBF DEVICE
    K Number
    K103228
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Theken Spine, LLC
    Date Received
    November 2, 2010
    Decision Date
    January 5, 2011
    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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