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

    PolyLock Plating System

    K Number: K211843 · Decision Mar 4, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    2
    Review Days
    262

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    Basic Information

    Device Name
    PolyLock Plating System
    K Number
    K211843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fusion Orthopedics
    Date Received
    June 15, 2021
    Decision Date
    March 4, 2022
    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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