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

    FIXATION SYSTEM

    K Number: K983318 · Decision Mar 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    14
    Review Days
    161

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    Basic Information

    Device Name
    FIXATION SYSTEM
    K Number
    K983318
    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
    General Surgical Innovations
    Date Received
    September 21, 1998
    Decision Date
    March 1, 1999
    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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    Other Clearances by General Surgical Innovations

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    K961356 MAMMARY SIZER
    K952278 THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA
    K951878 SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA
    K944418 THE SPACEMAKER AND THE SPACEMAKER II
    K944536 GSI KNOTMAKER
    K943671 GSI CANNULA REDUCER ACCESSORY
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