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

    InFill Interbody Fusion Device

    K Number: K152259 · Decision Nov 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    12
    Review Days
    100

    Basic Information

    Device Name
    InFill Interbody Fusion Device
    K Number
    K152259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pinnacle Spine Group, LLC
    Date Received
    August 11, 2015
    Decision Date
    November 19, 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 Pinnacle Spine Group, LLC

    K Number Device Name
    K172349 InFill® Interbody Fusion Device
    K151184 InFill Interbody Fusion Devices
    K150206 InFill Interbody Fusion Devices
    K143488 InFill Graft Delivery System
    K140066 INFILL CERVICAL
    K133721 INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60
    K124012 INFILL OBLIQUE TLIF DEVICE
    K121476 INFILL GRAFT DELIVERY SYSTEM
    K121733 INFILL INTERVERTEBRAL BODY FUSION DEVICE
    K111632 INFILL GRAFT DELIVERY SYSTEM
    Search all 12 clearances from Pinnacle Spine Group, LLC →