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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 4 of 16

Device	Model / Reference	Registries	Class	Status
Align	16-18551312-SP	FDA UDI	Class II	Active
Stabilis	35-18150805	FDA UDI	Class II	Active
Align	16-18451407	FDA UDI	Class II	Active
Align	14-50000002	FDA UDI	Class II	Active
Align	16-18451107-SP	FDA UDI	Class II	Active
Align	16-18401712-SP	FDA UDI	Class II	Active
Align	16-18401707	FDA UDI	Class II	Active
Stabilis	35-16140715	FDA UDI	Class II	Active
Stabilis	35-18151010	FDA UDI	Class II	Active
Stabilis	35-18151015	FDA UDI	Class II	Active
A Link Z	13-328152	FDA UDI	Class II	Active
Stabilis	35-16140610	FDA UDI	Class II	Active
Stabilis	30-14120710-SP	FDA UDI	Class II	Active
Align	16-18500912-SP	FDA UDI	Class II	Active
A Link Z	13-368152	FDA UDI	Class II	Active
Stabilis	35-16141215	FDA UDI	Class II	Active
Stabilis	35-14120505	FDA UDI	Class II	Active
Stabilis	35-20160700	FDA UDI	Class II	Active
Align	16-22550807	FDA UDI	Class II	Active
Align	16-22550907-SP	FDA UDI	Class II	Active
Align	16-18450812	FDA UDI	Class II	Active
Stabilis	30-18150910-SP	FDA UDI	Class II	Active
A Link Z	10-621112	FDA UDI	Class II	Active
Align	16-18501512	FDA UDI	Class II	Active
Align	16-18551407	FDA UDI	Class II	Active
Align	14-38301507-SP	FDA UDI	Class II	Active
A Link Z	10-000061	FDA UDI	Class II	Active
A Link Z	14-38301916	FDA UDI	Class II	Active
Stabilis	35-18151000	FDA UDI	Class II	Active
Stabilis	35-16140910	FDA UDI	Class II	Active
Stabilis	35-16140905	FDA UDI	Class II	Active
A Link Z	11-140003	FDA UDI	Class II	Active
Align	16-18551312	FDA UDI	Class II	Active
Stabilis	30-16140605-SP	FDA UDI	Class II	Active
A Link Z	10-000038	FDA UDI	Class II	Active
Align	16-18501107-SP	FDA UDI	Class II	Active
A Link Z	10-000063	FDA UDI	Class II	Active
A Link Z	15-32211107	FDA UDI	Class II	Active
A Link Z	13-368112	FDA UDI	Class II	Active
A Link Z	14-38301716	FDA UDI	Class II	Active
Stabilis	30-16141015-SP	FDA UDI	Class II	Active
Align	16-22600912	FDA UDI	Class II	Active
Align	16-18401112	FDA UDI	Class II	Active
A Link Z	11-270003	FDA UDI	Class II	Active
A Link Z	10-000077	FDA UDI	Class II	Active
Stabilis	30-14120610-SP	FDA UDI	Class II	Active
Stabilis	35-14120800	FDA UDI	Class II	Active
Stabilis	30-18151115-SP	FDA UDI	Class II	Active
Stabilis	35-20161215	FDA UDI	Class II	Active
Stabilis	35-16141010	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.