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510(k) Data Aggregation

    K Number
    K093086
    Device Name
    ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080
    Manufacturer
    ORTHODYNAMIX, LLC
    Date Cleared
    2010-02-23

    (145 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHODYNAMIX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ArthroSteer Ablator and Coagulator are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissue in joints including, but not limited to, the knee, shoulder, wrist and hip.
    Device Description
    Not Found
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