BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Jabil8683 (DK) - Cougar System, Concorde Bullet Spinal System

    Reg #: 8043792 · FEI: 3002808269 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Synergy Health Daniken AG
    Registration Number
    8043792
    FEI Number
    3002808269
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HOGENWEIDSTRASSE 6
    City
    Daniken Solothurn
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K140759

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10042227
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    US Agent

    Business Name
    STERIS Corporation
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 3927490

    Products

    Device Name Product Code
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    Jabil8683 (DK) - Cougar System, Concorde Bullet Spinal System Jabil8683 (DK) - Devex System, Bengal Stackable Cage System, Stackable Cage System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)