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

    Shoulder Innovations Total Shoulder System

    K Number: K213615 · Decision Mar 11, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    18
    Applicant Total
    8
    Review Days
    116

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    Basic Information

    Device Name
    Shoulder Innovations Total Shoulder System
    K Number
    K213615
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shoulder Innovations, Inc.
    Date Received
    November 15, 2021
    Decision Date
    March 11, 2022
    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 Shoulder Innovations, Inc.

    K Number Device Name
    K254128 InSet Reverse Total Shoulder System
    K252516 N22 EZ Glenosphere
    K252221 Inset Reverse Total Shoulder System
    K241817 InSet Total Shoulder System
    K210533 Inset Reverse Total Shoulder System
    K192365 Shoulder Innovations Total Shoulder System
    K173824 Humeral Short Stem System