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

    Elite L Expandable Lumbar Fusion System

    K Number: K150954 · Decision May 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    Elite L Expandable Lumbar Fusion System
    K Number
    K150954
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innova Spinal Technologies, LLC
    Date Received
    April 9, 2015
    Decision Date
    May 7, 2015
    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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    Other Clearances by Innova Spinal Technologies, LLC

    K Number Device Name
    K133459 ELITE IBF