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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 2 of 16

Device	Model / Reference	Registries	Class	Status
Align	16-18451007	FDA UDI	Class II	Active
Stabilis	35-18151115	FDA UDI	Class II	Active
Align	16-18501307-SP	FDA UDI	Class II	Active
A Link Z	10-000037	FDA UDI	Class II	Active
Stabilis	35-18150505	FDA UDI	Class II	Active
A Link Z	13-368192	FDA UDI	Class II	Active
Stabilis	35-20160815	FDA UDI	Class II	Active
Align	16-22601107-SP	FDA UDI	Class II	Active
A Link Z	16-36261712	FDA UDI	Class II	Active
A Link Z	10-621116	FDA UDI	Class II	Active
Align	16-22601112	FDA UDI	Class II	Active
A Link Z	10-000062	FDA UDI	Class II	Active
Align	16-22500807-SP	FDA UDI	Class II	Active
A Link Z	14-36261712	FDA UDI	Class II	Active
A Link Z	11-002555	FDA UDI	Class II	Active
A Link Z	10-000044	FDA UDI	Class II	Active
A Link Z	13-328112	FDA UDI	Class II	Active
Align	16-22551012-SP	FDA UDI	Class II	Active
A Link Z	10-000042	FDA UDI	Class II	Active
Stabilis	35-16141210	FDA UDI	Class II	Active
Align	14-38301712-SP	FDA UDI	Class II	Active
Align	16-22450807	FDA UDI	Class II	Active
Align	14-32211520-SP	FDA UDI	Class II	Active
Align	16-22501312	FDA UDI	Class II	Active
Align	14-36261516-SP	FDA UDI	Class II	Active
A Link Z	16-36261320	FDA UDI	Class II	Active
Align	14-38301112-SP	FDA UDI	Class II	Active
A Link Z	10-621156	FDA UDI	Class II	Active
Stabilis	35-14121200	FDA UDI	Class II	Active
Stabilis	30-18150810-SP	FDA UDI	Class II	Active
Stabilis	30-18151210-SP	FDA UDI	Class II	Active
A Link Z	15-32211320	FDA UDI	Class II	Active
A Link Z	14-36261520	FDA UDI	Class II	Active
A Link Z	13-328157	FDA UDI	Class II	Active
Align	16-22450912	FDA UDI	Class II	Active
Stabilis	35-18150905	FDA UDI	Class II	Active
A Link Z	15-32241707	FDA UDI	Class II	Active
Align	14-27271512-SP	FDA UDI	Class II	Active
Stabilis	35-18150500	FDA UDI	Class II	Active
A Link Z	14-38301712	FDA UDI	Class II	Active
Align	16-22601712-SP	FDA UDI	Class II	Active
Align	16-18451512	FDA UDI	Class II	Active
Align	16-18450912	FDA UDI	Class II	Active
Align	12-32211307	FDA UDI	Class II	Active
Align	16-18401312-SP	FDA UDI	Class II	Active
Stabilis	35-16140705	FDA UDI	Class II	Active
Stabilis	30-18151110-SP	FDA UDI	Class II	Active
Align	16-18450907	FDA UDI	Class II	Active
Stabilis	30-14121215-SP	FDA UDI	Class II	Active
Align	16-22551007	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.