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510(k) Data Aggregation

    K Number
    K972760
    Device Name
    LINK, ACETABULAR REVISION MESH CUP
    Manufacturer
    LINK AMERICA, INC.
    Date Cleared
    1997-10-22

    (90 days)

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

    LINK, ACETABULAR REVISION MESH CUP

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

    Cases of acetabular erosion or protrusio are not un-common. These problems are usually caused by a prior, failed acetabular implant, or a trauma induced fracture, or as a result of progressive joint disease. The surgical re-construction of the acetabular it is necessary to restore the floor or defect in the natural acetabular joint cavity. Using the mesh cup or mesh sheet as a scaffold. This creates a sound foundation or base for the definitive load bearing acetabular cup replacement devise:

    Device Description

    Link Acetabular Mesh Cup and Sheet

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Acetabular Revision Mesh and Cup" (Link America, Inc. Acetabular Mesh Cup and Sheet). It confirms substantial equivalence and permits marketing of the device.

    The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document focusing on substantial equivalence to previously marketed devices. Therefore, I cannot extract the requested details from the given input.

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