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

    Ignite Stemless Anatomic Shoulder System

    K Number: K203108 · Decision Jul 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    274

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    Basic Information

    Device Name
    Ignite Stemless Anatomic Shoulder System
    K Number
    K203108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ignite Orthopedics, LLC
    Date Received
    October 15, 2020
    Decision Date
    July 16, 2021
    Product Code
    PKC
    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
    PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

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    Other Clearances by Ignite Orthopedics, LLC

    K Number Device Name
    K202716 Ignite Anatomic Shoulder System