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

    MDS Plating System

    K Number: K172786 · Decision Dec 8, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    MDS Plating System
    K Number
    K172786
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Miami Device Solutions, LLC
    Date Received
    September 15, 2017
    Decision Date
    December 8, 2017
    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 Miami Device Solutions, LLC

    K Number Device Name
    K182810 Distal Radius Plating System
    K162898 Olecranon Plating System
    K162635 Distal Radius Plating System
    K161292 Distal Radius Plating System
    K161058 Cannulated Screw