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510(k) Data Aggregation

    K Number
    K072991
    Device Name
    PATRIOT SPACERS: COLONIAL ACDF
    Manufacturer
    GLOBUS MEDICAL, INC.
    Date Cleared
    2008-01-18

    (87 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PATRIOT SPACERS: COLONIAL ACDF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PATRIOT™ Spacers (Colonial™ ACDF) are interbody fusion devices 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 non-operative treatment. PATRIOT™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate System.

    Device Description

    PATRIOT™ Spacers (Colonial™ ACDF) are interbody fusion devices.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "PATRIOT Spacers". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the given input.

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