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510(k) Data Aggregation

    K Number
    K151661
    Device Name
    Renovo Life Hard Carbon Coated Drill Bit
    Manufacturer
    Renovo Life LLC
    Date Cleared
    2016-01-15

    (210 days)

    Product Code
    HTW
    Regulation Number
    888.4540
    Why did this record match?
    Product Code :

    HTW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Renovo Life Hard Carbon Coated Drill Bit is used to cut bone prior to insertion of bone screws or guide pins.
    Device Description
    Renovo Life Hard Carbon Coated Drill Bits are available in diameters ranging from 1.1 mm to 8.0 mm, lengths ranging from 60 mm to 300 mm, and either solid or cannulated. The drill bits are designed with a standard connections. Renovo Life Hard Carbon Coated Drill Bits are made of surgical grade stainless steel. The bone-cutting portion of the drill is coated with a hard carbon coating. Renovo Life Hard Carbon Coated Drill Bits are provided non-sterile and are intended for single use only.
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