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

    TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM

    K Number: K200575 · Decision Jul 9, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    5
    Review Days
    491

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    Basic Information

    Device Name
    TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
    K Number
    K200575
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Truemed Group, LLC
    Date Received
    March 5, 2020
    Decision Date
    July 9, 2021
    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 Truemed Group, LLC

    K Number Device Name
    K182650 Arzzt Distal Radius and Ulna System
    K172189 Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt
    K162507 Arzzt 3.5 / 4.5 Small & Large Fragments System
    K133166 INS HILDEN TIBIAL ARZZT