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510(k) Data Aggregation

    K Number
    K033944
    Device Name
    STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2004-03-12

    (84 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD

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

    The 32mm Modular Ceramic Femoral Head is a single use device used for reconstruction of the articulating surface of the femoral head portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head.

    Device Description

    StelKast 32mm Modular Ceramic Femoral Head

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA letter granting 510(k) clearance for the "StelKast 32mm Modular Ceramic Femoral Head" and its Indications For Use. It confirms the device's substantial equivalence to a legally marketed predicate device but does not detail any specific performance acceptance criteria or the results of a study to demonstrate compliance with such criteria.

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