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510(k) Data Aggregation

    K Number
    K251940

    Validate with FDA (Live)

    Device Name
    PathLoc Lumbar Plate System
    Manufacturer
    L & K Biomed Co., Ltd.
    Date Cleared
    2026-03-03

    (252 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K192481,K173885,K231839,K192678
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PathLoc Lumbar Plate System is indicated for use via the anterior surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion.

    This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc conformed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

    Device Description

    The system consists of plates and fixation screws manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136 standards, and it includes manual surgical instruments commonly used in general surgical procedures.

    AI/ML Overview

    N/A

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