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510(k) Data Aggregation

    K Number
    K152302
    Device Name
    Xenco Medical Cervical Interbody System (Argus)
    Manufacturer
    Xenco Medical, LLC
    Date Cleared
    2015-09-10

    (27 days)

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

    Xenco Medical Cervical Interbody System (Argus)

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

    Xenco Medical Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of non-operative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the "Xenco Medical Cervical Interbody System (Argus™)". It discusses substantial equivalence, regulatory compliance, and indications for use.

    However, this document does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

    Therefore, I cannot extract the information needed to answer your questions based on this text.

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