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

    OptiFix Open Absorbable Fixation System - 20 absorbable fasteners

    K Number: K163698 · Decision Apr 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    645
    Review Days
    103

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    Basic Information

    Device Name
    OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
    K Number
    K163698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    December 29, 2016
    Decision Date
    April 11, 2017
    Product Code
    GDW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GDW Staple, Implantable

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