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    K Number
    K251050

    Validate with FDA (Live)

    Device Name
    Pectus Versa System
    Manufacturer
    Gm Dos Reis Industria E Comercio
    Date Cleared
    2025-12-19

    (260 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K232829,K221938,K182718,K191057,K213712
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K232829, K221938, K182718

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

    The Pectus Versa System is indicated for the treatment of Pectus Excavatum and other anterior chest wall deformities in adult and pediatric patients (children and adolescents).

    Device Description

    The Pectus Versa System consists of implants for treating chest wall deformities in adult and pediatric patients (children and adolescents). When implanted, the bars exert an internal force on the chest wall, enabling the repositioning of the bone structure of the thorax. The system has connecting bars and stabilizers that assist in the assembly of complex systems, stabilizing the system and connecting two or more bars, enabling the surgeon to apply minimally invasive techniques for treating chest wall deformities.

    Pectus Versa System implants are manufactured with the following raw materials:

    • Titanium Alloy Ti6Al4V according to ASTM F136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications"
    AI/ML Overview

    N/A

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