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

    CONKLUSION PEDICLE SCREW SYSTEM

    K Number: K031455 · Decision Oct 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    302
    Applicant Total
    6
    Review Days
    168

    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
    CONKLUSION PEDICLE SCREW SYSTEM
    K Number
    K031455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Signus Medical, LLC
    Date Received
    May 7, 2003
    Decision Date
    October 22, 2003
    Product Code
    MNI
    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
    MNI Orthosis, Spinal Pedicle Fixation

    Similar 510(k) Clearances

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

    Mikron Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LumFix Spinal Fixation Sytem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Double Medical Universal Spine System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MySpine Pedicle Screw Placement Guides - LP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Premier

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

    Other Clearances by Signus Medical, LLC

    K Number Device Name
    K081108 MONOPOLY PEDICLE SCREW SYSTEM
    K052096 NUBIC SPINAL IMPLANT
    K031757 PEEK TETRIS SPINAL IMPLANT
    K022793 TETRIS SPINAL IMPLANT
    K020836 RABEA CEMENT RESTRICTOR