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510(k) Data Aggregation

    K Number
    K043181
    Device Name
    MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
    Manufacturer
    VERTEBRON, INC.
    Date Cleared
    2004-12-17

    (30 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K040003
    Predicate For
    K051815,K073530,K081567,K091396
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

    Device Description

    The material used is medical grade titanium material that conforms to ASTM F136.

    AI/ML Overview

    This is not an AI/ML device. It is a medical device for spinal fixation, not an AI diagnostic or prognostic tool. The provided text is a 510(k) summary and approval letter for a cervical plate system, not a study evaluating AI performance. Therefore, I cannot extract the requested information as it does not exist in the provided document.

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