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510(k) Data Aggregation

    K Number
    K052566

    Validate with FDA (Live)

    Device Name
    NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY
    Manufacturer
    ABBOTT SPINE, INC.
    Date Cleared
    2006-01-06

    (109 days)

    Product Code
    MNI
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K031985
    Predicate For
    K060634,K113346,K142752
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only . The multiaxial screws are not intended to be placed in the cervical spine.

    Device Description

    The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants. The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior spine. The subject devices share the same intended use and fundamental scientific technology as the predicates.

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for a spinal fixation system, not an AI/ML medical device. Therefore, the information requested in the prompt, such as acceptance criteria, performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is not applicable to this document.

    The document discusses the substantial equivalence of the "Nex-Link Spinal Fixation System" to a predicate device based on design modifications and non-clinical performance (laboratory and bench testing). It explicitly states: "Clinical data and conclusions were not needed for this submission."

    Therefore, I cannot provide the requested information as it pertains to AI/ML device studies.

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