ACUITY SURGICAL DEVICES, LLC

FDA Device Registration & Listing · Irving, TX, US · Registration 3010866843

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010866843
FEI Number
3010866843
Entity Name
ACUITY SURGICAL DEVICES, LLC
City/State/Country
Irving, TX, US
Establishment Address
8710 N Royal Lane, Irving, TX 75063, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Acuity Surgical Devices, LLC (Owner Number: 10046711)
Owner / Operator Contact Address
8710 N Royal Lane, Irving, TX 75063, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251735
PMA Number
N/A

All Registered Proprietary Names

Ventris Ti-Link P Ti-Link T Ti-Link C Ti-Link A Align sagAlign Tera A-Link Z A-Link Z Stabilis NF Vytex

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-11-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-11-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-05-01
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-05-01
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-12-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-12-22
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-12-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-12-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-12-22
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-11-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-11-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-04-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-11-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-10-28
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-05-17
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-04-10
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-11-17
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-11-17

Official Correspondent

Bryan Cowan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Acuity Surgical Devices, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K192492 Astura Medical, LLC EL CAPITAN Anterior Lumber Interbody System 2020-04-21
K212498 Nexus Spine, LLC Stable-L Standalone Lumbar Interbody System 2022-03-18
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010866843. Last updated year: 2026. Please use registration number 3010866843 when referencing this establishment in official correspondence.
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