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ACUITY SURGICAL DEVICES, LLC

Last updated September 17, 2026

Information

Country: US
Address: 8710 N Royal Lane, Irving, TX, 75063
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3010866843
DUNS Number: —

Catalogue (766)

Page 3 of 16

Device	Model / Reference	Registries	Class	Status
A Link Z	10-277132	FDA UDI	Class II	Active
Align	16-18451207	FDA UDI	Class II	Active
A Link Z	10-277190	FDA UDI	Class II	Active
A Link Z	10-277170	FDA UDI	Class II	Active
A Link Z	14-38301312	FDA UDI	Class II	Active
Align	16-18451507	FDA UDI	Class II	Active
A Link Z	14-36261916	FDA UDI	Class II	Active
A Link Z	11-328172	FDA UDI	Class II	Active
Stabilis	35-20161010	FDA UDI	Class II	Active
A Link Z	10-277117	FDA UDI	Class II	Active
Align	16-22551312-SP	FDA UDI	Class II	Active
Align	14-38301107-SP	FDA UDI	Class II	Active
Align	16-18550812-SP	FDA UDI	Class II	Active
Stabilis	30-20160610-SP	FDA UDI	Class II	Active
A Link Z	10-000043	FDA UDI	Class II	Active
A Link Z	14-38301520	FDA UDI	Class II	Active
Align	16-22551307-SP	FDA UDI	Class II	Active
A Link Z	16-28101107	FDA UDI	Class II	Active
Align	16-18500812-SP	FDA UDI	Class II	Active
Align	16-22601512	FDA UDI	Class II	Active
A Link Z	14-38301316	FDA UDI	Class II	Active
Align	12-32211312	FDA UDI	Class II	Active
Align	16-22451307	FDA UDI	Class II	Active
A Link Z	16-36261116	FDA UDI	Class II	Active
Stabilis	30-18150610-SP	FDA UDI	Class II	Active
Align	16-22500912	FDA UDI	Class II	Active
Align	16-18450812-SP	FDA UDI	Class II	Active
Align	16-18451007-SP	FDA UDI	Class II	Active
A Link Z	16-36261316	FDA UDI	Class II	Active
Stabilis	35-18151105	FDA UDI	Class II	Active
A Link Z	10-277176	FDA UDI	Class II	Active
Align	16-18400812	FDA UDI	Class II	Active
A Link Z	10-000051	FDA UDI	Class II	Active
Align	16-18501312-SP	FDA UDI	Class II	Active
A Link Z	16-28101007	FDA UDI	Class II	Active
A Link Z	10-000055	FDA UDI	Class II	Active
Align	16-22451507-SP	FDA UDI	Class II	Active
A Link Z	10-000059	FDA UDI	Class II	Active
Align	16-22550812	FDA UDI	Class II	Active
Stabilis	35-16140605	FDA UDI	Class II	Active
Align	11-103055-SP	FDA UDI	Class II	Active
Align	16-22401307-SP	FDA UDI	Class II	Active
Stabilis	30-18151015-SP	FDA UDI	Class II	Active
Align	16-18451112	FDA UDI	Class II	Active
Stabilis	35-20160910	FDA UDI	Class II	Active
Stabilis	30-18150705-SP	FDA UDI	Class II	Active
Align	16-18400807-SP	FDA UDI	Class II	Active
Stabilis	30-20160805-SP	FDA UDI	Class II	Active
A Link Z	10-621150	FDA UDI	Class II	Active
Align	16-22551112-SP	FDA UDI	Class II	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 7, 2019	Z-2354-2020	—	open, classified	Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Jan 7, 2019	Z-2355-2020	—	open, classified	Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.