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 6 of 16

Device	Model / Reference	Registries	Class	Status
A Link Z	10-621132	FDA UDI	Class II	Active
Align	16-22550707	FDA UDI	Class II	Active
Align	16-18401307-SP	FDA UDI	Class II	Active
Align	16-18451507-SP	FDA UDI	Class II	Active
A Link Z	14-27271012	FDA UDI	Class II	Active
Align	16-22451112-SP	FDA UDI	Class II	Active
A Link Z	13-328172	FDA UDI	Class II	Active
Align	16-18551107-SP	FDA UDI	Class II	Active
Stabilis	35-16140700	FDA UDI	Class II	Active
Align	16-18401107	FDA UDI	Class II	Active
Align	16-18401307	FDA UDI	Class II	Active
Stabilis	35-20160610	FDA UDI	Class II	Active
Align	14-38301316-SP	FDA UDI	Class II	Active
A Link Z	14-36261116	FDA UDI	Class II	Active
Align	16-18450707	FDA UDI	Class II	Active
Align	16-18450707-SP	FDA UDI	Class II	Active
Stabilis	35-18150800	FDA UDI	Class II	Active
A Link Z	11-003050	FDA UDI	Class II	Active
Align	16-18451307	FDA UDI	Class II	Active
Align	14-27271307-SP	FDA UDI	Class II	Active
Stabilis	30-16141115-SP	FDA UDI	Class II	Active
Align	16-22600807	FDA UDI	Class II	Active
Align	16-18551112-SP	FDA UDI	Class II	Active
Stabilis	35-16141115	FDA UDI	Class II	Active
Stabilis	30-18151205-SP	FDA UDI	Class II	Active
Align	16-18401312	FDA UDI	Class II	Active
A Link Z	13-368117	FDA UDI	Class II	Active
A Link Z	16-36261716	FDA UDI	Class II	Active
A Link Z	15-32211512	FDA UDI	Class II	Active
A Link Z	14-38301920	FDA UDI	Class II	Active
Stabilis	35-18150715	FDA UDI	Class II	Active
A Link Z	14-38301516	FDA UDI	Class II	Active
Align	14-27271112-SP	FDA UDI	Class II	Active
A Link Z	14-27271112	FDA UDI	Class II	Active
A Link Z	15-32241807	FDA UDI	Class II	Active
Align	16-18450807	FDA UDI	Class II	Active
Align	16-18500707-SP	FDA UDI	Class II	Active
Align	16-22551312	FDA UDI	Class II	Active
Align	16-18451712-SP	FDA UDI	Class II	Active
Stabilis	35-18151200	FDA UDI	Class II	Active
Align	16-22601112-SP	FDA UDI	Class II	Active
Align	16-18501312	FDA UDI	Class II	Active
Align	16-22601707-SP	FDA UDI	Class II	Active
Stabilis	35-18151210	FDA UDI	Class II	Active
A Link Z	11-002055	FDA UDI	Class II	Active
Align	14-27271107-SP	FDA UDI	Class II	Active
Stabilis	30-14121210-SP	FDA UDI	Class II	Active
A Link Z	15-32211912	FDA UDI	Class II	Active
Stabilis	30-14121015-SP	FDA UDI	Class II	Active
Stabilis	35-16140800	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.