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

    MLP Special Locking Bone Plate System

    K Number: K181843 · Decision Mar 4, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    505
    Registration Numbers
    505
    Same Product Code
    1254
    Applicant Total
    1
    Review Days
    236

    Basic Information

    Device Name
    MLP Special Locking Bone Plate System
    K Number
    K181843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maxxion Medical, LLC / Baumer SA
    Date Received
    July 11, 2018
    Decision Date
    March 4, 2019
    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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