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510(k) Data Aggregation

    K Number
    K121791
    Device Name
    ZOU ANTERIOR LUMBAR PLATE SYSTEM
    Manufacturer
    CORELINK LLC
    Date Cleared
    2012-11-19

    (153 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K091044,K082187,K061353,K022791,K052546
    Why did this record match?
    Device Name :

    ZOU ANTERIOR LUMBAR PLATE SYSTEM

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

    The CoreLink ZOUTM Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterior lateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels.

    The CoreLink ZOU™ Anterior Lumbar Plate System is designed to provide temporary stability until fixation is achieved. It is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

    Device Description

    The Zou® Anterior Lumbar Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The Zou® Anterior Lumbar Plate System is manufactured from Ti-6A1-4V ELI in accordance with ASTM F136.

    AI/ML Overview

    This is a 510(k) summary for a spinal fixation device, not a report about an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and human reader performance with AI assistance is not applicable and cannot be extracted from the provided text.

    The document discusses the substantial equivalence of the Zou® Anterior Lumbar Plate System to previously cleared predicate devices based on:

    • Indications For Use: Identical to predicate devices.
    • Design, Function, and Materials used: Similar to predicate devices.
    • Performance Standards: The device underwent testing based on a modified ASTM F1717 protocol, which included static compression bending, static torsion, and dynamic compression bending. The conclusion is that all substantial equivalence requirements were met.

    There is no mention of an algorithm or AI being used, nor any studies involving human readers or ground truth for diagnostic purposes.

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