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

    TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM

    K Number: K953076 · Decision Feb 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    77
    Applicant Total
    41
    Review Days
    609

    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
    TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
    K Number
    K953076
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sofamor Danek USA,Inc.
    Date Received
    June 30, 1995
    Decision Date
    February 28, 1997
    Product Code
    MRW
    Advisory Committee
    Unknown
    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
    MRW System, Facet Screw Spinal Device

    Similar 510(k) Clearances

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

    Ion-L

    FDA 510(k)
    FDA Unclassified ·Unknown

    CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)

    FDA 510(k)
    FDA Unclassified ·Unknown

    DiversiVy™ Facet Screw System

    FDA 510(k)
    FDA Unclassified ·Unknown

    Ion-C

    FDA 510(k)
    FDA Unclassified ·Unknown

    FFX Facet Fixation System

    FDA 510(k)
    FDA Unclassified ·Unknown

    CORUS-LX Implant

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Sofamor Danek USA,Inc.

    K Number Device Name
    K991031 COLORADO II SPINAL SYSTEM
    K984360 COLORADO II SPINAL SYSTEM
    K992928 CD HORIZON SPINAL SYSTEM
    K991036 DANEK PLATE AND SCREW SYSTEM
    K991198 DYNA-LOK PLUS SPINAL SYSTEM
    K991364 MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
    K981676 CD HORIZON SPINAL SYSTEM
    K980184 CD SPINAL SYSTEM
    K983672 DYNA-LOK SPINAL SYSTEM
    K983706 MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
    Search all 41 clearances from Sofamor Danek USA,Inc. →