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

    Ignite Anatomic Shoulder System

    K Number: K202716 · Decision May 20, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    36
    Applicant Total
    2
    Review Days
    245

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    Basic Information

    Device Name
    Ignite Anatomic Shoulder System
    K Number
    K202716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3670
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ignite Orthopedics, LLC
    Date Received
    September 17, 2020
    Decision Date
    May 20, 2021
    Product Code
    MBF
    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
    MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

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    Other Clearances by Ignite Orthopedics, LLC

    K Number Device Name
    K203108 Ignite Stemless Anatomic Shoulder System