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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 1 of 16

Device	Model / Reference	Registries	Class	Status
A Link Z	14-27271512	FDA UDI	Class II	Active
Stabilis	35-20160500	FDA UDI	Class II	Active
Stabilis	35-16140500	FDA UDI	Class II	Active
Align	16-22401512-SP	FDA UDI	Class II	Active
Align	14-32211307-SP	FDA UDI	Class II	Active
Align	35-50000001-2	FDA UDI	Class II	Active
Stabilis	30-20160715-SP	FDA UDI	Class II	Active
Stabilis	30-16141205-SP	FDA UDI	Class II	Active
A Link Z	16-36261512	FDA UDI	Class II	Active
A Link Z	14-32241507	FDA UDI	Class II	Active
Align	16-22551512-SP	FDA UDI	Class II	Active
Align	16-22551712-SP	FDA UDI	Class II	Active
A Link Z	14-36261316	FDA UDI	Class II	Active
Stabilis	35-18151005	FDA UDI	Class II	Active
A Link Z	14-38301512	FDA UDI	Class II	Active
A Link Z	10-621117	FDA UDI	Class II	Active
Stabilis	30-14121115-SP	FDA UDI	Class II	Active
A Link Z	10-277157	FDA UDI	Class II	Active
A Link Z	15-32211307	FDA UDI	Class II	Active
Align	16-18401712	FDA UDI	Class II	Active
Align	16-22501707-SP	FDA UDI	Class II	Active
Align	16-18550707	FDA UDI	Class II	Active
A Link Z	14-27271212	FDA UDI	Class II	Active
Stabilis	35-14120810	FDA UDI	Class II	Active
Align	14-38301716-SP	FDA UDI	Class II	Active
Stabilis	30-16140815-SP	FDA UDI	Class II	Active
Stabilis	35-14121015	FDA UDI	Class II	Active
A Link Z	10-000069	FDA UDI	Class II	Active
A Link Z	10-000034	FDA UDI	Class II	Active
Stabilis	30-18150605-SP	FDA UDI	Class II	Active
Align	35-50000001-1	FDA UDI	Class II	Active
Align	16-18401512-SP	FDA UDI	Class II	Active
Align	14-38301516-SP	FDA UDI	Class II	Active
A Link Z	14-32211112	FDA UDI	Class II	Active
A Link Z	10-277130	FDA UDI	Class II	Active
Align	16-22450912-SP	FDA UDI	Class II	Active
Stabilis	35-20160905	FDA UDI	Class II	Active
Align	16-22600912-SP	FDA UDI	Class II	Active
Align	16-22450812-SP	FDA UDI	Class II	Active
Align	16-22401112-SP	FDA UDI	Class II	Active
Align	16-18451312-SP	FDA UDI	Class II	Active
Stabilis	30-16141110-SP	FDA UDI	Class II	Active
Stabilis	30-20160710-SP	FDA UDI	Class II	Active
Align	16-22550807-SP	FDA UDI	Class II	Active
A Link Z	10-277196	FDA UDI	Class II	Active
Align	16-22500907	FDA UDI	Class II	Active
Align	16-18500707	FDA UDI	Class II	Active
Stabilis	35-20160710	FDA UDI	Class II	Active
Align	16-18550907-SP	FDA UDI	Class II	Active
Align	16-22550912-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.