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

    InFill Graft Delivery System

    K Number: K143488 · Decision Dec 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    12
    Review Days
    9

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    Basic Information

    Device Name
    InFill Graft Delivery System
    K Number
    K143488
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pinnacle Spine Group, LLC
    Date Received
    December 8, 2014
    Decision Date
    December 17, 2014
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMF Syringe, Piston

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    Other Clearances by Pinnacle Spine Group, LLC

    K Number Device Name
    K172349 InFill® Interbody Fusion Device
    K152259 InFill Interbody Fusion Device
    K151184 InFill Interbody Fusion Devices
    K150206 InFill Interbody Fusion Devices
    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 →