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510(k) Data Aggregation

    K Number
    K200816
    Device Name
    SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
    Manufacturer
    SpineEX, Inc.
    Date Cleared
    2020-04-30

    (31 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K181531,K190193
    Predicate For
    K223065
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

    Device Description

    The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are manufactured out of medical grade Ti-6A1-4V (Grade 5) and Ti-6A-4V (ELI) alloy that conforms to ASTM F1472 and ASTM F136 respectively.

    AI/ML Overview

    This document describes the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices, a medical device, and its substantial equivalence to previously cleared predicate devices. It does not contain information about the acceptance criteria and study results for a software device or an AI algorithm.

    Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets those criteria, as this information is not present in the provided text. The document focuses on regulatory approval based on comparison to existing devices rather than a performance study of a new, distinct device with specific performance metrics.

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