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

    NEON SYSTEM

    K Number: K113346 · Decision Feb 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    24
    Review Days
    106

    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
    NEON SYSTEM
    K Number
    K113346
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ulrich GmbH & Co. KG
    Date Received
    November 14, 2011
    Decision Date
    February 28, 2012
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

    Similar 510(k) Clearances

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

    LnK Posterior Cervical Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OASYS System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sure Lok Mini Posterior Cervical/Upper Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Reliance Posterior Cervical-Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Streamline OCT Occipito-Cervico-Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLSTICE OCT System

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

    Other Clearances by Ulrich GmbH & Co. KG

    K Number Device Name
    K252281 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
    K251295 ulrichINJECT CT Motion (XD 8000)
    K241850 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
    K233737 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
    K210541 ulrichINJECT CT motion
    K202227 Artus™ cervical plate system
    K192872 ulrichINJECT CT Motion
    K192117 Small VBR™
    K171392 ulrichINJECT CT motion
    K161032 neon3™ universal OCT spinal stabilization
    Search all 24 clearances from Ulrich GmbH & Co. KG →