Data / Medical devices / United States / Acuity Surgical Devices, LLC

Acuity Surgical Devices, LLC: FDA-registered device maker in Irving, TX, United States, 13 510(k) clearances

Name: Acuity Surgical Devices, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Acuity Surgical Devices, LLC is registered with the FDA (registration 3010866843) in Irving, TX, United States. It lists 10 device types. The FDA files 13 510(k) clearances under its listings, the newest dated July 30, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010866843
Address: 8710 N Royal Lane, Irving, TX, United States, 75063
Owner or operator: Acuity Surgical Devices, Inc. (10046711)
Roles: Manufacturer, Repackager or relabeler
First device listed: May 1, 2014
Registered through: 2026
Brand names listed: A-Link Z, Align, Align Lumbar Interbody Body Fusion System, Stabilis NF, Tera, Ti-Link A, Ti-Link C, Ti-Link P and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Repackager or relabeler	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Repackager or relabeler	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Repackager or relabeler	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 30, 2025	K251735	Stabilis SA Cervical Stand-Alone System (Various PNs)	OVE	Substantially Equivalent	Acuity Surgical Devices, LLC	accessdata.fda.gov
June 2, 2025	K251335	Tera Lumbar Interbody Fusion System (Various PNs)	MAX	Substantially Equivalent	Acuity Surgical Devices, LLC	accessdata.fda.gov
April 22, 2025	K243386	Ventris Intervertebral Body Fusion Device	OVD	Substantially Equivalent	Acuity Surgical Devices, LLC	accessdata.fda.gov
July 17, 2024	K241413	sagAlign Lumbar Cage System (Various PNs)	MAX	Substantially Equivalent	Acuity Surgical Devices, LLC	accessdata.fda.gov
December 1, 2023	K230639	Align Cervical Interbody Fusion System	ODP	Substantially Equivalent	Acuity Surgical Devices, LLC	accessdata.fda.gov
September 23, 2022	K222561	Align	OVD	Substantially Equivalent	Acuity Surgical Devices, LLC	accessdata.fda.gov
July 22, 2022	K221535	Align Lumbar Interbody Fusion System	MAX	Substantially Equivalent	Acuity Surgical Devices, LLC	accessdata.fda.gov
May 4, 2021	K201671	A-Link Z	OVD	Substantially Equivalent	Acuity Surgical Devices, LLC	accessdata.fda.gov
May 22, 2015	K143683	APEX-DL Spine System	NKB	Substantially Equivalent	Spinecraft, LLC	accessdata.fda.gov
May 19, 2015	K150417	ASTRA SPINE SYSTEM	NKB	Substantially Equivalent	Spinecraft, LLC	accessdata.fda.gov
November 17, 2014	K133827	A-LINK Z	OVD	Substantially Equivalent	Osteo Vasive, LLC	accessdata.fda.gov
September 30, 2013	K130573	TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF	ODP	Substantially Equivalent	Tyber Medical, LLC	accessdata.fda.gov
June 30, 2008	K080537	L-VARLOCK	MAX	Substantially Equivalent	Kiscomedica S.A.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 7, 2019	85642	Class II	Ongoing	A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Ca	Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.	accessdata.fda.gov

Compare with other makers

Updated July 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.