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

    Barricaid Instrument Tray

    K Number: K201676 · Decision Jul 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    27

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    Basic Information

    Device Name
    Barricaid Instrument Tray
    K Number
    K201676
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.4510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intrinsic Therapeutics, Inc.
    Date Received
    June 19, 2020
    Decision Date
    July 16, 2020
    Product Code
    QHG
    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
    QHG Defect Measurement Tool