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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 10 of 16

Device	Model / Reference	Registries	Class	Status
Align	16-22601712	FDA UDI	Class II	Active
Stabilis	35-18150700	FDA UDI	Class II	Active
A Link Z	14-27271307	FDA UDI	Class II	Active
Align	14-32211707-SP	FDA UDI	Class II	Active
Align	16-22601107	FDA UDI	Class II	Active
Stabilis	30-20161005-SP	FDA UDI	Class II	Active
Align	16-18451307-SP	FDA UDI	Class II	Active
Align	16-22401112	FDA UDI	Class II	Active
Align	16-22501007	FDA UDI	Class II	Active
A Link Z	14-36261312	FDA UDI	Class II	Active
Align	16-22501507-SP	FDA UDI	Class II	Active
Align	16-22401512	FDA UDI	Class II	Active
Stabilis	35-14120710	FDA UDI	Class II	Active
Stabilis	30-20161115-SP	FDA UDI	Class II	Active
Align	14-32211116-SP	FDA UDI	Class II	Active
Align	16-22601307-SP	FDA UDI	Class II	Active
Stabilis	35-20160900	FDA UDI	Class II	Active
Align	16-18451107	FDA UDI	Class II	Active
Align	16-22551307	FDA UDI	Class II	Active
Stabilis	30-14120810-SP	FDA UDI	Class II	Active
A Link Z	13-368177	FDA UDI	Class II	Active
Align	14-38301520-SP	FDA UDI	Class II	Active
Align	14-27271707-SP	FDA UDI	Class II	Active
Align	14-36261507-SP	FDA UDI	Class II	Active
A Link Z	14-32241316	FDA UDI	Class II	Active
Align	16-22601007-SP	FDA UDI	Class II	Active
A Link Z	10-000052	FDA UDI	Class II	Active
A Link Z	11-328112	FDA UDI	Class II	Active
A Link Z	15-32241312	FDA UDI	Class II	Active
Align	12-32211507	FDA UDI	Class II	Active
Align	16-18500907	FDA UDI	Class II	Active
Stabilis	35-20160600	FDA UDI	Class II	Active
A Link Z	10-000016	FDA UDI	Class II	Active
Stabilis	30-14120605-SP	FDA UDI	Class II	Active
Stabilis	30-14121105-SP	FDA UDI	Class II	Active
A Link Z	15-32241607	FDA UDI	Class II	Active
Align	16-22451107	FDA UDI	Class II	Active
Stabilis	35-14120715	FDA UDI	Class II	Active
Align	16-22501107	FDA UDI	Class II	Active
Align	16-18501207	FDA UDI	Class II	Active
Stabilis	35-20161200	FDA UDI	Class II	Active
A Link Z	14-27270907	FDA UDI	Class II	Active
Align	16-22401712-SP	FDA UDI	Class II	Active
Align	12-32211316	FDA UDI	Class II	Active
A Link Z	10-000078	FDA UDI	Class II	Active
Align	16-22500707-SP	FDA UDI	Class II	Active
Align	14-38301312-SP	FDA UDI	Class II	Active
Align	16-18550707-SP	FDA UDI	Class II	Active
A Link Z	10-000010	FDA UDI	Class II	Active
A Link Z	11-328132	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.