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510(k) Data Aggregation

    K Number
    K133459
    Device Name
    ELITE IBF
    Manufacturer
    INNOVA SPINAL TECHNOLOGIES, LLC
    Date Cleared
    2014-03-06

    (114 days)

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

    ELITE IBF

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

    The ELITE™ IBF Expandable Lumbar Fusion System is indicated for use as intervertebral body fusion devices in skeletally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-S1. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are intended for use with autogenous bone graft and supplemental internal fixation systems such as a pedicle screw or anterior plating system.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a Premarket Notification (510(k)) letter from the FDA regarding the ELITE™ IBF Expandable Lumbar Fusion System. This document does not contain information about the acceptance criteria or a study proving the device meets those criteria. It is a regulatory clearance document, not a clinical study report. Therefore, I cannot extract the requested information from this text.

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