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

    BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM

    K Number: K132850 · Decision Mar 31, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    42
    Applicant Total
    7
    Review Days
    201

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    Basic Information

    Device Name
    BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
    K Number
    K132850
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5910
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rti Surgical, Inc.
    Date Received
    September 11, 2013
    Decision Date
    March 31, 2014
    Product Code
    GXQ
    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
    GXQ Dura Substitute

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