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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 8 of 16

Device	Model / Reference	Registries	Class	Status
A Link Z	15-32211316	FDA UDI	Class II	Active
Stabilis	30-18151215-SP	FDA UDI	Class II	Active
A Link Z	10-000033	FDA UDI	Class II	Active
A Link Z	14-27271607	FDA UDI	Class II	Active
Align	16-22451307-SP	FDA UDI	Class II	Active
Align	16-18500812	FDA UDI	Class II	Active
A Link Z	16-36261720	FDA UDI	Class II	Active
A Link Z	10-000039	FDA UDI	Class II	Active
A Link Z	14-32241512	FDA UDI	Class II	Active
A Link Z	14-38301307	FDA UDI	Class II	Active
Stabilis	30-14121010-SP	FDA UDI	Class II	Active
Stabilis	35-14120610	FDA UDI	Class II	Active
Align	12-32211107	FDA UDI	Class II	Active
Stabilis	30-20161210-SP	FDA UDI	Class II	Active
Align	16-18451712	FDA UDI	Class II	Active
Align	16-22450707	FDA UDI	Class II	Active
A Link Z	10-000076	FDA UDI	Class II	Active
Stabilis	30-20160815-SP	FDA UDI	Class II	Active
Align	16-22501112	FDA UDI	Class II	Active
Align	16-18450807-SP	FDA UDI	Class II	Active
A Link Z	14-27271707	FDA UDI	Class II	Active
Stabilis	35-14120905	FDA UDI	Class II	Active
Align	16-18551012	FDA UDI	Class II	Active
Align	16-18551307	FDA UDI	Class II	Active
Stabilis	30-20160905-SP	FDA UDI	Class II	Active
Align	16-22500812-SP	FDA UDI	Class II	Active
Stabilis	30-18150815-SP	FDA UDI	Class II	Active
Align	16-22551112	FDA UDI	Class II	Active
Align	16-18451312	FDA UDI	Class II	Active
A Link Z	14-32241712	FDA UDI	Class II	Active
Align	12-32211320	FDA UDI	Class II	Active
A Link Z	16-36261112	FDA UDI	Class II	Active
Align	16-22451712	FDA UDI	Class II	Active
Align	16-18501107	FDA UDI	Class II	Active
A Link Z	15-32211712	FDA UDI	Class II	Active
A Link Z	14-27271407	FDA UDI	Class II	Active
A Link Z	15-32241207	FDA UDI	Class II	Active
Align	16-22501712-SP	FDA UDI	Class II	Active
Align	16-18550912-SP	FDA UDI	Class II	Active
A Link Z	16-28100707	FDA UDI	Class II	Active
A Link Z	10-621137	FDA UDI	Class II	Active
Align	16-18401112-SP	FDA UDI	Class II	Active
Align	14-36261316-SP	FDA UDI	Class II	Active
Align	16-18401107-SP	FDA UDI	Class II	Active
Align	16-18400707	FDA UDI	Class II	Active
Align	16-18551307-SP	FDA UDI	Class II	Active
A Link Z	16-36261516	FDA UDI	Class II	Active
Stabilis	35-16141200	FDA UDI	Class II	Active
Stabilis	30-18150710-SP	FDA UDI	Class II	Active
Stabilis	30-18151010-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.