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510(k) Data Aggregation

    K Number
    K234128
    Device Name
    Phantom Fibula Nail System
    Manufacturer
    Paragon 28, Inc.
    Date Cleared
    2024-08-22

    (238 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K143276,K163014,K173656
    Why did this record match?
    Device Name :

    Phantom Fibula Nail System

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

    The Phantom Fibula Nail System is intended for use in the fixation of fibular fractures and osteotomies.

    Device Description

    The Phantom Fibula Nail System consists of nails, screws, and accessories for the intended use of fibula repair. The implants are provided in multiple sizes and lengths.

    AI/ML Overview

    This FDA 510(k) summary does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device, as the Phantom Fibula Nail System is a physical medical device (intramedullary fixation rod) and not an AI/ML product.

    Therefore, the requested information components (1 through 9) related to AI/ML device performance, ground truth, and study design are not applicable to this document. The document describes the substantial equivalence of the physical device to a predicate device through performance testing of the device components (e.g., ASTM F1264 for nails, ASTM F543 for screws, ASTM F1875 for corrosion).

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