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510(k) Data Aggregation

    K Number
    K021878
    Device Name
    ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS
    Manufacturer
    Date Cleared
    2003-03-04

    (270 days)

    Product Code
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESKA AMERICA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ESKA Modular Total Hip System Acetabular Components are indicated for uncemented use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and posttraumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries.
    Device Description
    The ESKA Modular Hip System Acetabular Components are modular components used in conjunction with the company's femoral stems, for the replacement of severely disabled hip joints. The system consists of porous acetabular shells, modular femoral heads, and modular acetabular liners. The acctabular components are porous coated hemispherical shells with modular UHMWPE inserts. Materials: The devices are manufactured from CoCrMo alloy, Ultra High Molecular Weight Polyethylene ( UHMWPE ), per ASTM and ISO standards. Function: The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma.
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