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510(k) Data Aggregation

    K Number
    K081400
    Device Name
    FANNING-PAPPAS MODULAR KNEE BEARING
    Manufacturer
    ENDOTEC, INC.
    Date Cleared
    2009-02-20

    (277 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FANNING-PAPPAS MODULAR KNEE BEARING

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

    The Fenning-Pappas, Modular Knee Bearing is intended for reconstruction or revision of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis, in knees having coirectable mity, and viable or reconstructable ligaments. valgus or var ..

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a medical device called "Fenning-Pappas, Modular Knee Bearing", indicating it has been found substantially equivalent to a legally marketed predicate device.

    The letter discusses regulatory classifications, general controls, and other administrative information related to marketing the device. It also includes the "Indications for Use" for the device, but it does not detail any performance metrics, study results, or acceptance criteria.

    Thus, I cannot provide the requested table and information as it is not present in the given text.

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