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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 15 of 16

Device	Model / Reference	Registries	Class	Status
A Link Z	16-28101307	FDA UDI	Class II	Active
A Link Z	14-32241716	FDA UDI	Class II	Active
Align	14-32211920-SP	FDA UDI	Class II	Active
A Link Z	14-36261716	FDA UDI	Class II	Active
A Link Z	16-28101207	FDA UDI	Class II	Active
A Link Z	10-000014	FDA UDI	Class II	Active
Stabilis	35-20161005	FDA UDI	Class II	Active
Align	12-32211720	FDA UDI	Class II	Active
Align	14-38301720-SP	FDA UDI	Class II	Active
Stabilis	30-16140715-SP	FDA UDI	Class II	Active
A Link Z	10-277152	FDA UDI	Class II	Active
Stabilis	30-18150805-SP	FDA UDI	Class II	Active
Stabilis	35-16141110	FDA UDI	Class II	Active
Stabilis	35-14120900	FDA UDI	Class II	Active
A Link Z	10-277197	FDA UDI	Class II	Active
Align	16-18550807-SP	FDA UDI	Class II	Active
Align	16-22501107-SP	FDA UDI	Class II	Active
A Link Z	10-277172	FDA UDI	Class II	Active
Stabilis	35-16140710	FDA UDI	Class II	Active
Stabilis	35-14121110	FDA UDI	Class II	Active
A Link Z	15-32211720	FDA UDI	Class II	Active
Align	16-18501007	FDA UDI	Class II	Active
A Link Z	10-277150	FDA UDI	Class II	Active
Align	16-22451707	FDA UDI	Class II	Active
A Link Z	15-32211716	FDA UDI	Class II	Active
Align	14-32211916-SP	FDA UDI	Class II	Active
Stabilis	30-16140915-SP	FDA UDI	Class II	Active
Align	16-22601507	FDA UDI	Class II	Active
Align	16-22600707	FDA UDI	Class II	Active
Align	16-22450707-SP	FDA UDI	Class II	Active
Align	16-22601012-SP	FDA UDI	Class II	Active
Align	16-18451112-SP	FDA UDI	Class II	Active
Stabilis	35-16140815	FDA UDI	Class II	Active
A Link Z	15-32241912	FDA UDI	Class II	Active
A Link Z	14-32211316	FDA UDI	Class II	Active
Align	16-22550907	FDA UDI	Class II	Active
A Link Z	14-27271812	FDA UDI	Class II	Active
A Link Z	14-27271507	FDA UDI	Class II	Active
Stabilis	35-18151205	FDA UDI	Class II	Active
A Link Z	10-000079	FDA UDI	Class II	Active
Stabilis	35-16141005	FDA UDI	Class II	Active
Stabilis	30-18150915-SP	FDA UDI	Class II	Active
Stabilis	30-20161110-SP	FDA UDI	Class II	Active
A Link Z	14-38301507	FDA UDI	Class II	Active
Align	16-18551007-SP	FDA UDI	Class II	Active
Stabilis	35-16140915	FDA UDI	Class II	Active
Align	16-22551507-SP	FDA UDI	Class II	Active
Align	16-22550912	FDA UDI	Class II	Active
Align	16-22451312	FDA UDI	Class II	Active
Align	16-22450807-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.