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

    RADIX CERVICAL PLATE

    K Number: K033951 · Decision Jul 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    4
    Review Days
    192

    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
    RADIX CERVICAL PLATE
    K Number
    K033951
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pisharodi Surgicals, Inc.
    Date Received
    December 22, 2003
    Decision Date
    July 1, 2004
    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 Pisharodi Surgicals, Inc.

    K Number Device Name
    K070335 SIMPLEX CERVICAL FIXATION SYSTEM
    K024313 MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
    K014302 UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM