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

    Redemption Duo Hindfoot Nail System

    K Number: K231343 · Decision Jan 30, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    17
    Review Days
    266

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Redemption Duo Hindfoot Nail System
    K Number
    K231343
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vilex, LLC
    Date Received
    May 9, 2023
    Decision Date
    January 30, 2024
    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

    Other Clearances by Vilex, LLC

    K Number Device Name
    K260900 DYNEX® External Fixation Systems
    K250304 TITANEX Screw Systems
    K240475 Hintermann Series H2 Total Ankle System
    K243408 TACTIX Vector Syndesmosis System
    K233816 REDEMPTION Charcot Plating System
    K240035 TACTIX Vector Syndesmosis System
    K231504 TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
    K231493 NITINEX Memory Compression Staple
    K230462 OPTIX H2 Patient Specific Instrument System
    K230204 ALPHALOK Plating System
    Search all 17 clearances from Vilex, LLC →