BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Taps for Resorbable Screws

    K Number: K153587 · Decision Jan 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    16
    Applicant Total
    45
    Review Days
    399

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    Basic Information

    Device Name
    Taps for Resorbable Screws
    K Number
    K153587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4300
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (USA) Products, LLC
    Date Received
    December 16, 2015
    Decision Date
    January 18, 2017
    Product Code
    HBG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBG Drills, Burrs, Trephines & Accessories (Manual)

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