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

    GMReis Fibula Nail System

    K Number: K250559 · Decision Jun 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    2
    Review Days
    107

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    Basic Information

    Device Name
    GMReis Fibula Nail System
    K Number
    K250559
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gm Dos Reis Industria E Comercio
    Date Received
    February 25, 2025
    Decision Date
    June 12, 2025
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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