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

    Endoskeleton TCS Interbody Fusion Device

    K Number: K191565 · Decision Aug 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    54

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    Basic Information

    Device Name
    Endoskeleton TCS Interbody Fusion Device
    K Number
    K191565
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Titan Spine, Inc.
    Date Received
    June 13, 2019
    Decision Date
    August 6, 2019
    Product Code
    OVE
    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
    OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

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    Other Clearances by Titan Spine, Inc.

    K Number Device Name
    K191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
    K192054 Endoskeleton TAS Plate
    K192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
    K183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device