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510(k) Data Aggregation

    K Number
    K011856
    Device Name
    RADIOGRAPHIC MARKERS
    Manufacturer
    ENCORE ORTHOPEDICS, INC.
    Date Cleared
    2001-08-22

    (70 days)

    Product Code
    NEU,FZP
    Regulation Number
    878.4300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K010348
    Predicate For
    K061066
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Radiographic Markers are intended for implantation in the bone to aid the surgeon in radiographic assessment of total hip or knee component movement.

    Device Description

    The Radiographic Markers are spherical in shape and available in 00.8-1.0 mm. The Radiographio hauters antalum conforming to the composition called out in ASTM F560-98.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Radiographic Markers) and does not contain a study demonstrating the device meets acceptance criteria. The document states that the device is substantially equivalent to a predicate device based on comparable materials, design, and indications for use. Therefore, I cannot provide the requested information.

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