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

    Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System

    K Number: K190498 · Decision Jul 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    6
    Review Days
    127

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    Basic Information

    Device Name
    Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System
    K Number
    K190498
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
    Date Received
    February 28, 2019
    Decision Date
    July 5, 2019
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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    Other Clearances by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

    K Number Device Name
    K200095 Streamline Navigated Instruments
    K192718 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
    K170830 Unison-C Anterior Cervical Fixation System
    K161876 Tritium® Sternal Cable Plate System
    K152793 Unison-C Anterior Cervical Fixation System