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

    WILTSE SYSTEM

    K Number: K992012 · Decision Feb 4, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    16
    Review Days
    234

    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
    WILTSE SYSTEM
    K Number
    K992012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Advanced Spine Fixation Systems, Inc.
    Date Received
    June 15, 1999
    Decision Date
    February 4, 2000
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

    Similar 510(k) Clearances

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

    ARIES Anterior Cervical Plate Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CastleLoc-P Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    corra™ cervical plating system

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VyPlate™ Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANTERIS Thoracolumbar Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PathLoc Lumbar Plate System

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

    Other Clearances by Advanced Spine Fixation Systems, Inc.

    K Number Device Name
    K990845 MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15
    K954770 CENTRA-LINE GRAPPLE, VARIFIX SYSTEM
    K953779 SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM
    K953778 SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM
    K953369 STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW
    K951308 5.8MM DIAMETER ANCHOR SCREW
    K951172 TITANIUM LOW PROFILE CROSS BAR
    K945064 SELBY INSTRUMENTATION
    K943775 SELBY INSTRUMENTATION
    K942387 SELBY INSTRUMENTATION
    Search all 16 clearances from Advanced Spine Fixation Systems, Inc. →