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

    Fusion FibFix Nail

    K Number: K252961 · Decision Mar 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    1
    Review Days
    183

    Basic Information

    Device Name
    Fusion FibFix Nail
    K Number
    K252961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fusion Orthopedics USA, LLC
    Date Received
    September 16, 2025
    Decision Date
    March 18, 2026
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

    Similar 510(k) Clearances

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

    AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Precice™ Max System and Precice™ Ankle Salvage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Fule Metallic Lockable Intramedullary Nail Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HERA Interlocking Intramedullary Nailing System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FITBONE® TRANSPORT AND LENGTHENING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA

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