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510(k) Data Aggregation

    K Number
    K955807
    Date Cleared
    1996-10-01

    (284 days)

    Product Code
    Regulation Number
    888.3050
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    COTREL-DUBOUSSET (CD) SPINAL

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

    The CD spinal screws, when used as pedicle screws with the CD™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and(d) who are having the device removed after the development of a solid fusion mass. Otherwise, the CD screws, when used in posterior fixation, are intended for sacral/iliac attachment only. Except for situations where stainless steel screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a CD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the CD Spinal System (either stainless steel or titanium alloy versions) are the following:

    1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by radiographic studies).
    2. Pseudoarthrosis
    3. Stenosis
    4. Spondylolisthesis
    5. Spinal deformities: scoliosis, kyphosis, and lordosis
    6. Fracture
    7. Unsuccessful previous attempts at spinal fusion
    8. Tumor resection
      All of the CD hooks are intended for posterior thoracic and/or lumbar use only. CD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.
    Device Description

    The CDTM Spinal System consists of rods, hooks, screws, connectors, cross connectors, and other components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CD™ Spinal System is to provide stabilization during the development of a solid spinal fusion. The CD™ Spinal System implant components are fabricated from ASTM F138 or its ISO equivalent stainless steel and may be sold sterile or non-sterile. Implant components made from different metal alloys must not be used together in a construct.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about a device that uses artificial intelligence or any study conducted to assess its performance against acceptance criteria. The document describes the Cotrel-Dubousset (CD™) Spinal System, which appears to be a medical implant system for spinal stabilization, not an AI-powered device.

    Therefore, I cannot provide the requested table and details about acceptance criteria, study design, expert involvement, or AI-specific performance metrics as this information is not present in the given input.

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