BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ICOTEC AG

    Reg #: 3006493760 · FEI: 3006493760 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    ICOTEC AG
    Registration Number
    3006493760
    FEI Number
    3006493760
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Industriestrasse 12
    City
    Altstaetten Sankt Gallen
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K232790

    Owner / Operator

    Firm Name
    icotec ag
    Operator Number
    10042564
    Address
    Industriestrasse 12
    City
    Altstaetten
    State
    Sankt Gallen
    Postal Code
    9450
    Country
    CH
    Correspondent
    Vanessa Faessler

    US Agent

    Business Name
    MCRA, LLC
    Contact Name
    Justin Eggleton
    Address
    803 7th Street NW
    City
    Washington
    State
    DC
    ZIP
    20001
    Country
    US
    Email
    [email protected]
    Phone
    202 5525804

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Bone Cement, Posterior Screw Augmentation PML
    Spinal Vertebral Body Replacement Device MQP
    Spinal Vertebral Body Replacement Device - Cervical PLR

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device