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510(k) Data Aggregation

    K Number
    K032729
    Device Name
    Z-SERIES MODULAR TOTAL HIP SYSTEM
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2003-12-03

    (91 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Z™ - Series Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, specifically an approval letter for a medical device. It does not contain information about acceptance criteria or a study proving that a device meets such criteria.

    The document states that the FDA has reviewed the 510(k) premarket notification for the "Z™-Series Modular Total Hip System" and found it to be substantially equivalent to legally marketed predicate devices. This is a regulatory determination, not a statement about performance against specific acceptance criteria from a study.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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