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

    G3(TM) Active Plate(R) Small Fragment System

    K Number: K160633 · Decision Apr 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    5
    Review Days
    46

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    Basic Information

    Device Name
    G3(TM) Active Plate(R) Small Fragment System
    K Number
    K160633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genesis Fracture Care, Inc.
    Date Received
    March 7, 2016
    Decision Date
    April 22, 2016
    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 Genesis Fracture Care, Inc.

    K Number Device Name
    K171293 G3™ Active Plate® Miniature System
    K152242 G3¿ Active Plate® Large Fragment System
    K150649 G3 Active Plate Large Fragment System
    K142938 G3 Active Plate Large Fragment System