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

    Unison-C Anterior Cervical Fixation System

    K Number: K170830 · Decision Jun 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    161
    Applicant Total
    6
    Review Days
    100

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    Basic Information

    Device Name
    Unison-C Anterior Cervical Fixation System
    K Number
    K170830
    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
    March 20, 2017
    Decision Date
    June 28, 2017
    Product Code
    OVE
    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
    OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

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

    K Number Device Name
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    K192718 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
    K190498 Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System
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    K152793 Unison-C Anterior Cervical Fixation System