BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MOBIS II spinal implant system (PEEK variant)

    Reg #: 9615021 · FEI: 1000615957 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    SIGNUS MEDIZINTECHNIK GMBH
    Registration Number
    9615021
    FEI Number
    1000615957
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Industriestrasse 2
    City
    ALZENAU Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K131372

    Owner / Operator

    Firm Name
    SIGNUS Medizintechnik GmbH
    Operator Number
    9034279
    Address
    Industriestrasse 2
    City
    ALZENAU
    State
    DE-NOTA
    Postal Code
    D-63755
    Country
    DE
    Correspondent
    Susanne Siedler

    US Agent

    Business Name
    German American Chamber of Commerce, Inc.
    Contact Name
    German American Chamber of Commerce, Inc. German American Ch
    Address
    80 Pine Street, 24th Floor
    City
    New York
    State
    NY
    ZIP
    10005
    Country
    US
    Email
    [email protected]
    Phone
    212 9748830

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    MOBIS II spinal implant system (PEEK variant)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device