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

    SHOULDER FIXATION SYSTEM

    K Number: K042059 · Decision Sep 30, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    56
    Applicant Total
    10
    Review Days
    62

    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
    SHOULDER FIXATION SYSTEM
    K Number
    K042059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hand Innovations, Inc.
    Date Received
    July 30, 2004
    Decision Date
    September 30, 2004
    Product Code
    LXT
    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
    LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

    Similar 510(k) Clearances

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

    Para-Fix External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POLARUS CONNECT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DISTAL VOLAR RADIUS PLATING SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS

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

    Other Clearances by Hand Innovations, Inc.

    K Number Device Name
    K050932 DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
    K041157 MODIFICATION TO SMALL BONE FIXATION SYSTEM
    K041081 FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
    K033406 SMALL BONE FIXATION SYSTEM
    K032705 DISTAL RADIUS FRACTURE REPAIR SYSTEM
    K030198 HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM
    K023007 DISTAL RADIUS FRACTURE REPAIR SYSTEM
    K013424 INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
    K002775 DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM