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510(k) Data Aggregation

    K Number
    K231090
    Device Name
    Zevo Anterior Cervical Plate System
    Manufacturer
    Medtronic Sofamor Danek USA, Inc.
    Date Cleared
    2023-06-15

    (59 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K141632
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ZEVO™ Anterior Cervical Plate System is interior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) turnors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions

    Device Description

    The ZEVO™ Anterior Cervical Plate System consists of temporary implants (plates and bone screws) intended for anterior screw fixation of the cervical spine during the development of a cervical spinal fusion. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The device is intended for the anterior screw fixation from C2- T1 in the cervical spine.

    The ZEVO™ Anterior Cervical Plate System implants are available in a broad range of size offerings, and are supplied in both sterile and non-sterile form.

    The implant components are made from titanium alloy, with plates having subcomponents manufacturing from nitinol (NiTi).

    The purpose of this submission is to establish MR Conditional labeling for this implant system.

    AI/ML Overview

    This submission (K231090) describes the ZEVO™ Anterior Cervical Plate System. However, this document does not contain information regarding an AI/ML device.

    The purpose of this submission is to establish MR Conditional labeling for this implant system. The document focuses on demonstrating the magnetic resonance (MR) safety of the ZEVO™ Anterior Cervical Plate System through non-clinical testing.

    Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or adjudication methods related to an AI/ML device, as this document does not pertain to such a device.

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