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510(k) Data Aggregation

    K Number
    K260448

    Validate with FDA (Live)

    Device Name
    CastleLoc Pectus Bar System
    Manufacturer
    L&K BIOMED Co., Ltd.
    Date Cleared
    2026-03-19

    (36 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K250892,K243357
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CastleLoc Pectus Bar System is indicated for the treatment of Pectus Excavatum and other anterior chest deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

    Device Description

    The CastleLoc Pectus Bar System is a thoracic support product that repairs the thoracic wall, using minimally invasive surgical techniques to elevate the ribs and sternum to correct a type of chest wall deformity called pectus excavatum. Recommended implantation time is 2-3 years but may vary based on surgeon preference and patient.

    This system includes various sizes of straight and curved CastleLoc Pectus Bars. The appropriate bar is selected based on suitability for the patient body size. The CastleLoc Pectus Bar, and CastleLoc Pectus Stabilizer, Nut and CastleLoc Pectus Claw Fixator for fixing the CastleLoc Pectus Bar, are made of Ti-6Al-4V (ASTM F136).

    AI/ML Overview

    N/A

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