Is this your brand? Sign in to claim ownership.

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 13 of 16

Device	Model / Reference	Registries	Class	Status
A Link Z	14-32211507	FDA UDI	Class II	Active
A Link Z	14-38301707	FDA UDI	Class II	Active
Stabilis	30-14120915-SP	FDA UDI	Class II	Active
Align	16-22401507	FDA UDI	Class II	Active
Stabilis	35-20160800	FDA UDI	Class II	Active
Align	16-18551012-SP	FDA UDI	Class II	Active
A Link Z	14-32211307	FDA UDI	Class II	Active
Align	16-22601507-SP	FDA UDI	Class II	Active
Stabilis	35-16141015	FDA UDI	Class II	Active
Stabilis	30-18150905-SP	FDA UDI	Class II	Active
Align	16-22601012	FDA UDI	Class II	Active
Stabilis	35-16141205	FDA UDI	Class II	Active
Align	14-36261116-SP	FDA UDI	Class II	Active
Align	16-18400912-SP	FDA UDI	Class II	Active
Align	16-18501307	FDA UDI	Class II	Active
Align	16-22401507-SP	FDA UDI	Class II	Active
Stabilis	35-18150910	FDA UDI	Class II	Active
Stabilis	35-20161110	FDA UDI	Class II	Active
Stabilis	30-16140905-SP	FDA UDI	Class II	Active
A Link Z	13-328137	FDA UDI	Class II	Active
Stabilis	35-16141105	FDA UDI	Class II	Active
Align	16-22551107-SP	FDA UDI	Class II	Active
A Link Z	15-32241407	FDA UDI	Class II	Active
Align	14-36261307-SP	FDA UDI	Class II	Active
Align	16-18451012-SP	FDA UDI	Class II	Active
Align	14-32211512-SP	FDA UDI	Class II	Active
Stabilis	30-14120905-SP	FDA UDI	Class II	Active
Align	16-18450912-SP	FDA UDI	Class II	Active
Align	16-22600907	FDA UDI	Class II	Active
Align	16-22550707-SP	FDA UDI	Class II	Active
Align	12-32211707	FDA UDI	Class II	Active
A Link Z	13-328117	FDA UDI	Class II	Active
Align	16-18501507-SP	FDA UDI	Class II	Active
A Link Z	14-36261516	FDA UDI	Class II	Active
Stabilis	35-18150600	FDA UDI	Class II	Active
A Link Z	15-32241107	FDA UDI	Class II	Active
A Link Z	14-38301112	FDA UDI	Class II	Active
A Link Z	16-36261520	FDA UDI	Class II	Active
Align	14-27270907-SP	FDA UDI	Class II	Active
Align	16-18550912	FDA UDI	Class II	Active
A Link Z	14-36261507	FDA UDI	Class II	Active
Stabilis	30-20161015-SP	FDA UDI	Class II	Active
Align	12-32211512	FDA UDI	Class II	Active
Align	16-18451512-SP	FDA UDI	Class II	Active
A Link Z	15-32241907	FDA UDI	Class II	Active
Align	16-22450907-SP	FDA UDI	Class II	Active
Align	16-22501312-SP	FDA UDI	Class II	Active
Align	16-18501507	FDA UDI	Class II	Active
A Link Z	10-000080	FDA UDI	Class II	Active
Align	14-36261720-SP	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.