BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    SpineGuard DSG Zavation Screw System

    K Number: K162884 · Decision Jan 12, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    16
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    SpineGuard DSG Zavation Screw System
    K Number
    K162884
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4300
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spineguard S.A.
    Date Received
    October 14, 2016
    Decision Date
    January 12, 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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