BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ICOTEC AG

    Reg #: 3006493760 · FEI: 3006493760 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    ICOTEC AG
    Registration Number
    3006493760
    FEI Number
    3006493760
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Industriestrasse 12
    City
    Altstaetten Sankt Gallen
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K190545

    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
    Ethan Naylor
    Address
    803 7th Street NW
    City
    Washington
    State
    DC
    ZIP
    20001
    Country
    US
    Email
    [email protected]
    Phone
    571 3961248

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Bone Cement, Posterior Screw Augmentation PML
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Spinal Vertebral Body Replacement Device MQP
    Posterior Cervical Screw System NKG
    Orthopedic Stereotaxic Instrument OLO
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthopedic Manual Surgical Instrument LXH

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device