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510(k) Data Aggregation

    K Number
    K063782
    Device Name
    ACCIN UNI-KNEE SYSTEM
    Manufacturer
    ACCIN CORPORATION
    Date Cleared
    2007-01-19

    (29 days)

    Product Code
    HSX
    Regulation Number
    888.3520
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCIN CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of: Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis; Correction of functional deformities: Revision of previous unsuccessful unicompartmental knee replacement or other procedure; As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. These components are single use only and are intended for implantation with bone cement.
    Device Description
    The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and tibial tray and a polyethylene tibial insert.
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    K Number
    K060670
    Device Name
    ACCIN UNI-KNEE SYSTEM
    Manufacturer
    ACCIN CORPORATION
    Date Cleared
    2006-06-02

    (80 days)

    Product Code
    HSX
    Regulation Number
    888.3520
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCIN CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of: - Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis; - Correction of functional deformities; - Revision of previous unsuccessful unicompartmental knee replacement or other procedure; - As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. These components are single use only and are intended for implantation with bone cement.
    Device Description
    The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and tibial tray and a polyethylene tibial insert.
    Ask a Question

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