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

    OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM

    K Number: K042073 · Decision Feb 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    5
    Review Days
    189

    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
    OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
    K Number
    K042073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olsen Medical
    Date Received
    August 2, 2004
    Decision Date
    February 7, 2005
    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 Olsen Medical

    K Number Device Name
    K130669 SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS
    K111262 ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP
    K080187 OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS
    K072937 OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET