BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    COLIGNE AG

    Reg #: 1000493591 · FEI: 1000493591 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    COLIGNE AG
    Registration Number
    1000493591
    FEI Number
    1000493591
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    UTOQUAI 43
    City
    ZURICH
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K210306

    Owner / Operator

    Firm Name
    COLIGNE AG
    Operator Number
    9033198
    Address
    UTOQUAI 43, --
    City
    ZURICH
    State
    CH-ZH
    Postal Code
    8008
    Country
    CH
    Correspondent
    ROBERT B LANGE

    US Agent

    Business Name
    New Road Enterprises, Inc
    Contact Name
    David Young
    Address
    1951 33rd St.
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US
    Email
    [email protected]
    Phone
    303 4445972

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Spinal Vertebral Body Replacement Device MQP
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Spinal Vertebral Body Replacement Device - Cervical PLR

    Proprietary Names

    GII OstaPek VBR System ostaPek ostaPek Interbody Fusion Cages ACIF GII Spinal Fixation System Trabis

    Establishment Types

    Manufacture Medical Device