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510(k) Data Aggregation

    K Number
    K071795
    Device Name
    NUVASIVE COROENT SYSTEM
    Manufacturer
    NUVASIVE, INC.
    Date Cleared
    2007-12-04

    (155 days)

    Product Code
    MAX,MOP
    Regulation Number
    888.3080
    Type
    Abbreviated
    Panel
    Orthopedic
    Reference & Predicate Devices
    K071922
    Predicate For
    K081673,K082128,K082235,K090425,K092815,K093242,K101051,K103382,K103666,K103729,K110454,K111166,K111512,K113138,K120918,K121096,K121116,K121567,K122989,K123045,K123758,K130820,K131082,K131723,K132601,K132897,K133455,K133557,K140007,K140055,K140319,K140563,K140659,K140709,K141665,K141896,K151214,K152943,K160916,K171151,K171633
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intervertebral Body Fusion

    The NuVasive CoRoent System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

    The CoRoent L and XL platforms are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

    Partial Vertebral Body Replacement

    The NuVasive CoRoent System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

    Device Description

    The NuVasive CoRoent System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

    AI/ML Overview

    The provided text is a 510(k) summary for the NuVasive CoRoent System, an intervertebral body fusion device.

    This document describes the device, its intended use, and states that substantial equivalence was demonstrated through non-clinical mechanical testing.

    Crucially, the document explicitly states: "H. Summary of Clinical Tests (Not Applicable)."

    Therefore, based on the provided text, there is no information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or MRMC studies. The approval for this device was based on substantial equivalence to a predicate device and non-clinical mechanical testing, not on clinical performance metrics or studies involving human data or expert review as you've requested.

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