BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    OstaPek VBR System

    Reg #: 1000493591 · FEI: 1000493591 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COLIGNE AG
    Registration Number
    1000493591
    FEI Number
    1000493591
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    UTOQUAI 43
    City
    ZURICH
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K072326

    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
    Spinal Vertebral Body Replacement Device MQP

    Proprietary Names

    OstaPek VBR System

    Establishment Types

    Manufacture Medical Device