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

    VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES

    K Number: K031687 · Decision Apr 30, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    33
    Review Days
    333

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    Basic Information

    Device Name
    VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K Number
    K031687
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vanguard Medical Concepts, Inc.
    Date Received
    June 2, 2003
    Decision Date
    April 30, 2004
    Product Code
    KTT
    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
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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    Other Clearances by Vanguard Medical Concepts, Inc.

    K Number Device Name
    K053051 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K051616 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K051180 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K051043 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
    K050763 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
    K043198 VANGUARD REPROCESSED ARTHROSCOPIC WANDS
    K043253 VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
    K043594 VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
    K043225 VANGUARD REPROCESSED ULTRASONIC SCALPEL
    K043315 VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
    Search all 33 clearances from Vanguard Medical Concepts, Inc. →