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

    SnapHammer Hammertoe Correction System

    K Number: K250613 · Decision Apr 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    653
    Registration Numbers
    653
    Same Product Code
    1040
    Applicant Total
    1
    Review Days
    33

    Basic Information

    Device Name
    SnapHammer Hammertoe Correction System
    K Number
    K250613
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nvision Biomedical Technologies Inc
    Date Received
    February 28, 2025
    Decision Date
    April 2, 2025
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

    Similar 510(k) Clearances

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

    Eleganz Fusion Screw System (Fusion Screw System)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TriMed® Compression Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TITANEX Screw Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Caliber Intramedullary Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex SS VAL and VAL KreuLock™ Compression Screw System

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