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

    Augment Off-Axis Instrument System

    K Number: K233148 · Decision Mar 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    182
    Applicant Total
    2
    Review Days
    177

    Basic Information

    Device Name
    Augment Off-Axis Instrument System
    K Number
    K233148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fix Surgical
    Date Received
    September 27, 2023
    Decision Date
    March 22, 2024
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PHX), ordered by most recent decision date.

    SMR Reverse HP Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    restor3d Reverse Total Shoulder Arthroplasty System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JARVIS Glenoid Reverse Shoulder Prosthesis

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Equinoxe® Central Screw Baseplate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Fix Surgical

    K Number Device Name
    K241043 Augment Off-Axis Instrument System