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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 5 of 16

Device	Model / Reference	Registries	Class	Status
A Link Z	10-000068	FDA UDI	Class II	Active
Align	14-32211716-SP	FDA UDI	Class II	Active
A Link Z	10-000064	FDA UDI	Class II	Active
A Link Z	14-36261707	FDA UDI	Class II	Active
Align	16-22401707-SP	FDA UDI	Class II	Active
Align	16-22501512-SP	FDA UDI	Class II	Active
Align	14-27271907-SP	FDA UDI	Class II	Active
Align	11-140003-SP	FDA UDI	Class II	Active
Stabilis	30-14120815-SP	FDA UDI	Class II	Active
Align	16-18400812-SP	FDA UDI	Class II	Active
A Link Z	14-38301720	FDA UDI	Class II	Active
Align	11-102055-SP	FDA UDI	Class II	Active
Align	16-22451107-SP	FDA UDI	Class II	Active
Stabilis	35-18150705	FDA UDI	Class II	Active
Align	14-38301916-SP	FDA UDI	Class II	Active
Align	16-18550907	FDA UDI	Class II	Active
A Link Z	13-368172	FDA UDI	Class II	Active
A Link Z	14-27270912	FDA UDI	Class II	Active
Stabilis	30-18151105-SP	FDA UDI	Class II	Active
Align	14-32211720-SP	FDA UDI	Class II	Active
A Link Z	14-36261107	FDA UDI	Class II	Active
Stabilis	35-16140805	FDA UDI	Class II	Active
A Link Z	15-32241112	FDA UDI	Class II	Active
Stabilis	30-20161215-SP	FDA UDI	Class II	Active
Align	16-22500707	FDA UDI	Class II	Active
Align	16-18501712	FDA UDI	Class II	Active
Stabilis	30-20161205-SP	FDA UDI	Class II	Active
A Link Z	13-368137	FDA UDI	Class II	Active
A Link Z	10-000066	FDA UDI	Class II	Active
Align	16-18401007-SP	FDA UDI	Class II	Active
Align	16-18401707-SP	FDA UDI	Class II	Active
A Link Z	10-000067	FDA UDI	Class II	Active
A Link Z	10-000065	FDA UDI	Class II	Active
Align	16-22551007-SP	FDA UDI	Class II	Active
A Link Z	10-277192	FDA UDI	Class II	Active
Stabilis	30-18150715-SP	FDA UDI	Class II	Active
Align	14-36261112-SP	FDA UDI	Class II	Active
Align	16-22451012-SP	FDA UDI	Class II	Active
Align	16-22450812	FDA UDI	Class II	Active
Align	16-22600812-SP	FDA UDI	Class II	Active
Stabilis	35-18150915	FDA UDI	Class II	Active
Align	16-18500807-SP	FDA UDI	Class II	Active
Stabilis	30-20160915-SP	FDA UDI	Class II	Active
A Link Z	10-000056	FDA UDI	Class II	Active
Stabilis	30-20161105-SP	FDA UDI	Class II	Active
Stabilis	35-14120500	FDA UDI	Class II	Active
Align	14-36261920-SP	FDA UDI	Class II	Active
A Link Z	14-32241707	FDA UDI	Class II	Active
Stabilis	30-14120715-SP	FDA UDI	Class II	Active
A Link Z	15-32211516	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.