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510(k) Data Aggregation

    K Number
    K955730
    Device Name
    EBI ANTERIOR CERVICAL SPINE SYSTEM
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Date Cleared
    1996-03-13

    (86 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EBI Anterior Cervical Spine System is a single use device, intended for anterior cervical spine applications only Specific indications include the fusion, reduction, alignment or stabilization of the cervical segments of the spine in cases of degenerative disc disease (spondylosis of the cervical spine, cervical spondylotic myelopathy and cervical spondylosis neuropathy), trauma, and tumors.

    Device Description

    The EBI Anterior Cervical Spine System consists of spinal implant components and various instruments used during the implantation procedure. The spinal implants consist of plates, screws and locking screws. Materials: Ti-6AI-4V ELI alloy with or without Titanium nitride coating

    AI/ML Overview

    I apologize, but the provided text does not contain information about acceptance criteria or a study proving device performance as requested in your prompt. The text is a "Summary of Safety & Effectiveness for EBI Anterior Cervical Spine System," which describes a medical device, its intended use, and its comparison to predicate devices, focusing on the addition of a Titanium nitride (TiN) coating.

    Therefore, I cannot fulfill your request for the tables and details about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the given input.

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