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

    LEFORTE SYSTEM BONE PLATE

    K Number: K023360 · Decision Oct 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    37
    Applicant Total
    53
    Review Days
    18

    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
    LEFORTE SYSTEM BONE PLATE
    K Number
    K023360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jeil Medical Corporation
    Date Received
    October 7, 2002
    Decision Date
    October 25, 2002
    Product Code
    KTW
    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
    KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

    Similar 510(k) Clearances

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

    PK High Tibial Osteotomy Correction System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AOS Anterolateral Proximal Humeral Plate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Phantom Small Bone Intramedullary Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AOS Anterolateral Proximal Humeral Plate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AOS PROXIMAL HUMERAL PLATE

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

    Other Clearances by Jeil Medical Corporation

    K Number Device Name
    K252246 Leforte MMF System
    K252826 ARIX Femur Nail System
    K251431 FIX-C PEEK ACIF SA System
    K243973 FIX-L PEEK PLIF and T-PLIF System
    K242751 ARIX Pectus Bar System
    K242247 ARIX Femur Nail System
    K243915 FIX-C 3D Ti ACIF System
    K243004 Xpine Spinal Fixation System
    K231251 FlexWing Anterior Cervical Plate System
    K233912 ARIX Cannulated Screw System
    Search all 53 clearances from Jeil Medical Corporation →