BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ti-Link A

    Reg #: 3010866843 · FEI: 3010866843 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    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
    K130573

    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 Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    Ti-Link A Ti-Link T Ti-Link C Ti-Link P

    Establishment Types

    Repack or Relabel Medical Device