BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

    K Number: K242442 · Decision Jan 31, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    653
    Registration Numbers
    653
    Same Product Code
    1040
    Applicant Total
    1
    Review Days
    168

    Basic Information

    Device Name
    Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
    K Number
    K242442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovate Orthopaedics Ltd
    Date Received
    August 16, 2024
    Decision Date
    January 31, 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

    SnapHammer Hammertoe Correction System

    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

    Arthrex SS VAL and VAL KreuLock™ Compression Screw System

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