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

    T2 Alpha Tibia Nailing System, IMN Screws System

    K Number: K193308 · Decision Feb 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    7
    Review Days
    86

    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
    T2 Alpha Tibia Nailing System, IMN Screws System
    K Number
    K193308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Trauma GmbH
    Date Received
    November 29, 2019
    Decision Date
    February 23, 2020
    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 Stryker Trauma GmbH

    K Number Device Name
    K200869 Gamma3 System
    K191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
    K180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
    K172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
    K170418 Stryker SonicPin System
    K143063 Stryker SonicPin System, Stryker SonicAnchor System