BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Astura Medical

    Reg #: 3015941638 · FEI: 3011764740 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Astura Medical
    Registration Number
    3015941638
    FEI Number
    3011764740
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4949 W Royal Ln
    City
    Irving
    State
    TX
    ZIP
    75063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192492

    Owner / Operator

    Firm Name
    Astura Medical
    Operator Number
    10051052
    Address
    4949 W Royal Ln.
    City
    Irving
    State
    TX
    Postal Code
    75063
    Country
    US
    Correspondent
    Thomas Purcell

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198