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

    InSet Reverse Total Shoulder System

    K Number: K254128 · Decision Apr 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    203
    Applicant Total
    8
    Review Days
    112

    Basic Information

    Device Name
    InSet Reverse Total Shoulder System
    K Number
    K254128
    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
    December 22, 2025
    Decision Date
    April 13, 2026
    Product Code
    PHX
    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
    PHX Shoulder Prosthesis, Reverse Configuration

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