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

    Spineology Interbody Fusion System

    K Number: DEN200010 · Decision Sep 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    54
    Review Days
    212

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    Basic Information

    Device Name
    Spineology Interbody Fusion System
    K Number
    DEN200010
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    888.3085
    Medical Specialty
    Orthopedic
    Decision
    Unknown
    Applicant
    Spineology, Inc.
    Date Received
    February 19, 2020
    Decision Date
    September 18, 2020
    Product Code
    OQB
    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
    OQB Intervertebral Body Graft Containment Device

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    Other Clearances by Spineology, Inc.

    K Number Device Name
    K251302 OptiMesh Multiplanar Expandable Interbody Fusion System
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    K231781 OptiMesh Multiplanar Expandable Interbody Fusion System
    K213876 Spineology Navigation Instruments
    K210155 Duo Expandable Interbody Fusion System
    K192047 Rampart™ One Lumbar Interbody Fusion System
    K191091 Rampart One Lumbar Interbody Fusion System
    K190055 Duo Lumbar Interbody Fusion Device
    K182322 Duo Lumbar Interbody Fusion Device
    Search all 54 clearances from Spineology, Inc. →