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510(k) Data Aggregation

    K Number
    K040685
    Device Name
    Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2005-01-25

    (315 days)

    Product Code
    LWJ,JDI,KWL,KWY,LZO
    Regulation Number
    888.3360
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED

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

    The Z™ - Series Modular Total Hip System Plasma Coated is indicated for use in total or partial hip replacements in patients suffering severe pain and disability due to structural hip problems such as rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated in patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and failed previous fusion, where bone stock is inadequate for other reconstruction techniques. CP Titanium Plasma Coated Implants are intended for Cement or Press Fit Applications.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter for a medical device (Z-Series Modular Total Hip System Plasma Coated) and does not contain information about acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot extract the requested information from this text.

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