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510(k) Data Aggregation

    K Number
    K190055
    Device Name
    Duo Lumbar Interbody Fusion Device
    Manufacturer
    Spineology Inc.
    Date Cleared
    2019-03-07

    (55 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K182322,K181792,K123767
    Predicate For
    K210155
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

    Device Description

    The Duo Lumbar Interbody Fusion Device is an intervertebral implant designed to provide mechanical support of the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum. The Duo implant is available in varying lengths and heights with two lordotic configurations and is provided sterile. The device is designed with a porous central cavity for graft containment, a rounded nose to aid implant insertion, and ridged teeth to resist migration.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device (Duo Lumbar Interbody Fusion Device) and does not contain information about acceptance criteria, study methodologies, or performance metrics typically associated with AI/ML-based medical devices. This document is related to a traditional medical device and focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than algorithmic performance.

    Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets them for an AI/ML product from the given text. The provided document concerns a spinal implant and its surgical instruments, not an AI/ML device.

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