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

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

    K Number: K132704 · Decision Oct 9, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    41

    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
    DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
    K Number
    K132704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet
    Date Received
    August 29, 2013
    Decision Date
    October 9, 2013
    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 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

    SYNTHES (USA) ELBOW HINGE FIXATOR

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

    Other Clearances by Biomet

    K Number Device Name
    K133939 MODIFIED DISTAL RADIUS PLATING SYSTEM