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

    MotoCLIP/HiMAX Step Staple Implant System

    K Number: K181866 · Decision Aug 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    13
    Review Days
    28

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    Basic Information

    Device Name
    MotoCLIP/HiMAX Step Staple Implant System
    K Number
    K181866
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Crossroads Extremity Systems, LLC
    Date Received
    July 12, 2018
    Decision Date
    August 9, 2018
    Product Code
    JDR
    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
    JDR Staple, Fixation, Bone

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