LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K050462
    Device Name
    SBI HAND FIXATION SYSTEM (TM)
    Manufacturer
    SMALL BONE INNOVATIONS LLC
    Date Cleared
    2005-04-26

    (62 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMALL BONE INNOVATIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SBI Hand Fixation System™ is a system of plates and screws that is intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.
    Device Description
    The SBI Hand Fixation System™ consists of a series of stainless steel plates and screws of varying lengths and thicknesses and is provided in various configurations, including straight, T-, Y-, Z-, compression L-, compression T-, and compression Y-plates. These plates are attached to bone via 1.5, 1.7, 2.0, 2.2, 2.4, and 2.6mm self tapping cortex screws.
    Ask a Question

    Page 1 of 1