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

    IlluminOss Photodynamic Bone Stabilization System

    K Number: K201961 · Decision Aug 13, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    IlluminOss Photodynamic Bone Stabilization System
    K Number
    K201961
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3023
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Illuminoss Medical, Inc.
    Date Received
    July 14, 2020
    Decision Date
    August 13, 2020
    Product Code
    QAD
    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
    QAD Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

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    Other Clearances by Illuminoss Medical, Inc.

    K Number Device Name
    K233436 IlluminOss Photodynamic Bone Stabilization System
    K202887 IlluminOss Bone Stabilization System
    K200295 IlluminOss Bone Stabilization System
    K183145 IlluminOss Photodynamic Bone Stabilization System
    K181228 IlluminOss Bone Stabilization System