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510(k) Data Aggregation

    K Number
    K972411
    Device Name
    LINK CEMENT PLUG
    Manufacturer
    TURNKEY INTERGRATION USA, INC.
    Date Cleared
    1997-08-29

    (64 days)

    Product Code
    LZN
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LINK CEMENT PLUG

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

    The Link femoral cement restrictor plug system is used to constrict the flow of bone cement (PMMA) into the distal section of the femoral canal during a cemented total hip arthoplasty.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Link, Cement Plug" and its related "Femoral Cement Restrictor Plug System." It does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

    The letter is a regulatory document affirming that the device is substantially equivalent to a legally marketed predicate device, thereby allowing it to be marketed. It does not delve into the specific technical or clinical performance studies.

    Therefore, I cannot provide the requested information based on the provided text.

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