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510(k) Data Aggregation

    K Number
    K110110
    Device Name
    ATRIUM CENTRILFX MESH
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Date Cleared
    2011-02-15

    (32 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ATRIUM CENTRILFX MESH

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

    The Atrium CentriFX Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (Atrium CentriFX Mesh) and does not contain information related to the acceptance criteria or study details as one would find for an AI/ML medical device. This document is related to a surgical mesh, which is a physical implant, not a software algorithm.

    Therefore, I cannot provide the requested information.

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