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510(k) Data Aggregation

    K Number
    K051032
    Device Name
    TITANIUM-HIP TOOL
    Manufacturer
    ORTHOPEDIC SCIENCES, INC
    Date Cleared
    2005-05-23

    (31 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K022139
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Titanium-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) summary for the Titanium-Hip ToolTM. It indicates that the device is substantially equivalent to a previously cleared predicate device (Hip Tool™ Implant, K022139) and describes its intended use. However, it does not contain any information about acceptance criteria, performance studies, or clinical data that would typically be used to prove a device meets such criteria.

    Therefore, I cannot provide the requested table and information based on the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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