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

    Coronet Soft Tissue Fixation System

    K Number: K200028 · Decision Mar 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    2
    Review Days
    58

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    Basic Information

    Device Name
    Coronet Soft Tissue Fixation System
    K Number
    K200028
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Conextions Medical
    Date Received
    January 6, 2020
    Decision Date
    March 4, 2020
    Product Code
    MBI
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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