BEUDAMED
    FDA Registration Active 🇺🇸 United States

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    Reg #: 3010866843 · FEI: 3010866843 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ACUITY SURGICAL DEVICES, LLC
    Registration Number
    3010866843
    FEI Number
    3010866843
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8710 N Royal Lane
    City
    Irving
    State
    TX
    ZIP
    75063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201671

    Owner / Operator

    Firm Name
    Acuity Surgical Devices, LLC
    Operator Number
    10046711
    Address
    8710 N Royal Lane
    City
    Irving
    State
    TX
    Postal Code
    75063
    Country
    US
    Correspondent
    Bryan Cowan

    Products

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

    Proprietary Names

    A-Link Z

    Establishment Types

    Manufacture Medical Device