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510(k) Data Aggregation

    K Number
    K083389
    Device Name
    COALITION SPACER
    Manufacturer
    GLOBUS MEDICAL INC.
    Date Cleared
    2009-03-26

    (129 days)

    Product Code
    OVE
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K072991
    Predicate For
    K102323,K102547,K111439,K112068,K112388,K113796,K120840,K121151,K121569,K122630,K122771,K130478,K131449,K131951,K132029,K132999,K142218,K143578,K151939,K152022,K191477,K210382
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The COALITION™ Spacer is a stand-alone interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of nonoperative treatment. The COALITION™ Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

    Device Description

    The COALITION™ Spacer is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.

    The COALITION™ Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called the COALITION™ Spacer, an intervertebral body fusion device. This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training/ground truth details typically associated with AI/ML device evaluations.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval for a physical medical implant, not a software or AI/ML diagnostic tool.

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