BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    Mini and Micro Fragments Reconstruction System – GMReis

    K Number: K182718 · Decision Dec 23, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    3
    Review Days
    451

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    Basic Information

    Device Name
    Mini and Micro Fragments Reconstruction System – GMReis
    K Number
    K182718
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gm Dos Reis Industria E Comerico Ltda.
    Date Received
    September 28, 2018
    Decision Date
    December 23, 2019
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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