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

    Surgimatix Absorbable Fixation System

    K Number: K201934 · Decision Oct 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    2
    Review Days
    445

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    Basic Information

    Device Name
    Surgimatix Absorbable Fixation System
    K Number
    K201934
    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
    Surgimatix, Inc.
    Date Received
    July 13, 2020
    Decision Date
    October 1, 2021
    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 Surgimatix, Inc.

    K Number Device Name
    K132669 PROXIFAST ABSORBABLE STAPLE