BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACUITY SURGICAL DEVICES, LLC

    Reg #: 3010866843 · FEI: 3010866843 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    ACUITY SURGICAL DEVICES, LLC
    Registration Number
    3010866843
    FEI Number
    3010866843
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8710 N Royal Lane
    City
    Irving
    State
    TX
    ZIP
    75063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243386

    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
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    Ventris Ti-Link P Ti-Link T Ti-Link C Ti-Link A Align sagAlign Tera A-Link Z Stabilis NF Vytex sagAlign Lumbar Cage System Align Lumbar Interbody Body Fusion System

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device