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510(k) Data Aggregation

    K Number
    K223671
    Device Name
    CONDUIT LLIF Straight Inserters
    Manufacturer
    Enztec Limited
    Date Cleared
    2023-01-05

    (29 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K201605,K212823
    Why did this record match?
    Device Name :

    CONDUIT LLIF Straight Inserters

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CONDUIT™ LLIF Straight Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

    The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

    Device Description

    The CONDUIT™ LLIF Straight Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instruments have been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or to other instruments provided with the implants.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the CONDUIT™ LLIF Straight Inserters, which are instruments used to insert EIT Cellular Titanium® LLIF Cages during Lumbar Interbody Fusion surgery.

    However, the document does not contain information related to a study that uses AI or machine learning, nor does it discuss acceptance criteria and device performance in the context of AI. The performance data mentioned refers to non-clinical mechanical testing (impact endurance and thread endurance) for a surgical instrument, not an AI-powered diagnostic or assistive device.

    Therefore, I cannot provide a response to your request, as the provided text lacks the necessary information about acceptance criteria and a study proving an AI device meets those criteria.

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