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

    GEO 1st MTP Joint Arthrodesis Plating System

    K Number: K200108 · Decision Mar 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    5
    Review Days
    69

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    Basic Information

    Device Name
    GEO 1st MTP Joint Arthrodesis Plating System
    K Number
    K200108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gramercy Extremity Orthopedics, LLC
    Date Received
    January 17, 2020
    Decision Date
    March 26, 2020
    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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    Other Clearances by Gramercy Extremity Orthopedics, LLC

    K Number Device Name
    K212334 GEO Extremity and Ankle Plating System
    K210534 GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
    K202817 GEO Bone Screw System
    K182212 Geo Staple System