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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 12 of 16

Device	Model / Reference	Registries	Class	Status
Align	16-18451012	FDA UDI	Class II	Active
A Link Z	10-000060	FDA UDI	Class II	Active
Stabilis	35-20160715	FDA UDI	Class II	Active
Stabilis	35-14120605	FDA UDI	Class II	Active
Align	16-18501407	FDA UDI	Class II	Active
A Link Z	14-27271807	FDA UDI	Class II	Active
Stabilis	35-14121010	FDA UDI	Class II	Active
Align	16-18551007	FDA UDI	Class II	Active
Align	16-22501507	FDA UDI	Class II	Active
Align	16-22551107	FDA UDI	Class II	Active
A Link Z	14-32211312	FDA UDI	Class II	Active
Align	14-36261107-SP	FDA UDI	Class II	Active
Stabilis	30-14120910-SP	FDA UDI	Class II	Active
Align	16-18401512	FDA UDI	Class II	Active
Align	16-18501012	FDA UDI	Class II	Active
Align	16-18501112-SP	FDA UDI	Class II	Active
Align	16-18501007-SP	FDA UDI	Class II	Active
A Link Z	15-32211507	FDA UDI	Class II	Active
A Link Z	14-36261307	FDA UDI	Class II	Active
A Link Z	10-277137	FDA UDI	Class II	Active
Stabilis	30-16140610-SP	FDA UDI	Class II	Active
Stabilis	35-18150610	FDA UDI	Class II	Active
A Link Z	10-000036	FDA UDI	Class II	Active
Stabilis	30-16141210-SP	FDA UDI	Class II	Active
Align	16-18501712-SP	FDA UDI	Class II	Active
Stabilis	35-16141000	FDA UDI	Class II	Active
A Link Z	10-000057	FDA UDI	Class II	Active
Align	14-36261312-SP	FDA UDI	Class II	Active
A Link Z	16-28101407	FDA UDI	Class II	Active
Align	11-103050-SP	FDA UDI	Class II	Active
A Link Z	11-002050	FDA UDI	Class II	Active
A Link Z	14-32241516	FDA UDI	Class II	Active
Stabilis	30-18151005-SP	FDA UDI	Class II	Active
Align	14-32211712-SP	FDA UDI	Class II	Active
Stabilis	35-16140900	FDA UDI	Class II	Active
Align	14-32211507-SP	FDA UDI	Class II	Active
Stabilis	35-14120600	FDA UDI	Class II	Active
Align	16-22600707-SP	FDA UDI	Class II	Active
Align	12-32211716	FDA UDI	Class II	Active
Align	16-22401312-SP	FDA UDI	Class II	Active
Align	14-36261712-SP	FDA UDI	Class II	Active
Stabilis	30-14120505-SP	FDA UDI	Class II	Active
Align	14-32211312-SP	FDA UDI	Class II	Active
Stabilis	30-20160605-SP	FDA UDI	Class II	Active
Align	16-18501207-SP	FDA UDI	Class II	Active
Stabilis	30-14121005-SP	FDA UDI	Class II	Active
Align	12-32211712	FDA UDI	Class II	Active
Stabilis	35-16140810	FDA UDI	Class II	Active
Stabilis	30-16141105-SP	FDA UDI	Class II	Active
Stabilis	35-14121005	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.