BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Astura Medical

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

    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
    K233359

    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
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Spinal Vertebral Body Replacement Device MQP

    Establishment Types

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