LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K100707
    Device Name
    REPROCESSED PINS
    Manufacturer
    STERILMED, INC.
    Date Cleared
    2010-06-25

    (105 days)

    Product Code
    NDM
    Regulation Number
    888.3040
    Why did this record match?
    Product Code :

    NDM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pins are intended to be used to rigidly fixate a Tracker to a single bone during computer assisted surgical procedures including hip, knee, and other trauma applications. Specifically: - Navigation and Ortholock Ex-Pins: The intended use of the Stryker OrthoLock Ex-Pins is to . rigidly fixate a Tracker to the bone undergoing treatment. The Stryker OrthoLock Ex-Pins are intended to be used with, but are not limited to, the OrthoLock system. - Anchoring Pins: The Anchoring Pins are components of the Hip, Trauma and Knee Modules of . the Stryker Navigation System and intended to be used to rigidly fixate a Tracker to a single bone.
    Device Description
    Reprocessed Pins
    Ask a Question

    Page 1 of 1