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510(k) Data Aggregation

    K Number
    K032607
    Device Name
    POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
    Manufacturer
    LINVATEC CORP.
    Date Cleared
    2003-11-10

    (77 days)

    Product Code
    DZI,HBB,HSZ
    Regulation Number
    872.4120
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K981269,K832187,K020069
    Predicate For
    K062842
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PowerPro® Pneumatic System consists of handpieces and attachments intended to be used for cutting, drilling, tapping, reaming, and driving screws and pins in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

    Device Description

    The PowerPro® Pneumatic System is a pneumatically powered system consisting of handpieces and attachments for cutting bone in various large and small bone procedures. The PowerPro® Pneumatic handpieces are pistol-grip handpieces. The handpieces utilize various attachments, such as blades, burs, drills and routers that are also used with Linvatec's PowerPro® Electric and Battery Systems.

    AI/ML Overview

    This document is a 510(k) Summary of Safety and Effectiveness for the PowerPro® Pneumatic System. It states that the PowerPro® Pneumatic System is substantially equivalent to predicate devices and does not raise any new safety or effectiveness issues. However, it does not include specific acceptance criteria or details of a study demonstrating the device meets such criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence rather than a detailed performance study with defined acceptance criteria.

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