BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Renovo Life Hard Carbon Coated Drill Bit

    K Number: K151661 · Decision Jan 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    560
    Registration Numbers
    560
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    210

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    Basic Information

    Device Name
    Renovo Life Hard Carbon Coated Drill Bit
    K Number
    K151661
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renovo Life, LLC
    Date Received
    June 19, 2015
    Decision Date
    January 15, 2016
    Product Code
    HTW
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HTW Bit, Drill

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