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

    Grappler Interference Screw System

    K Number: K241864 · Decision Jul 25, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    564
    Applicant Total
    34
    Review Days
    28

    Basic Information

    Device Name
    Grappler Interference Screw System
    K Number
    K241864
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paragon 28, Inc.
    Date Received
    June 27, 2024
    Decision Date
    July 25, 2024
    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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