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 11 of 16

Device	Model / Reference	Registries	Class	Status
Stabilis	35-20161205	FDA UDI	Class II	Active
A Link Z	15-32241512	FDA UDI	Class II	Active
Stabilis	35-18150710	FDA UDI	Class II	Active
Stabilis	35-20160810	FDA UDI	Class II	Active
Align	16-18500912	FDA UDI	Class II	Active
Align	16-18400912	FDA UDI	Class II	Active
Stabilis	35-14121205	FDA UDI	Class II	Active
Stabilis	35-20160915	FDA UDI	Class II	Active
Align	16-22500812	FDA UDI	Class II	Active
Align	14-27270912-SP	FDA UDI	Class II	Active
Stabilis	30-16140810-SP	FDA UDI	Class II	Active
Align	16-22501012-SP	FDA UDI	Class II	Active
Stabilis	30-14120805-SP	FDA UDI	Class II	Active
Align	16-18500807	FDA UDI	Class II	Active
Stabilis	30-20160505-SP	FDA UDI	Class II	Active
Align	14-36261916-SP	FDA UDI	Class II	Active
Stabilis	35-14121210	FDA UDI	Class II	Active
A Link Z	14-27271207	FDA UDI	Class II	Active
A Link Z	10-277097	FDA UDI	Class II	Active
A Link Z	14-36261920	FDA UDI	Class II	Active
Align	12-32211520	FDA UDI	Class II	Active
Align	16-18400907	FDA UDI	Class II	Active
Align	16-22401307	FDA UDI	Class II	Active
Align	14-38301512-SP	FDA UDI	Class II	Active
Align	16-18400707-SP	FDA UDI	Class II	Active
A Link Z	10-621130	FDA UDI	Class II	Active
Align	12-32211112	FDA UDI	Class II	Active
Stabilis	35-14120805	FDA UDI	Class II	Active
Align	11-102555-SP	FDA UDI	Class II	Active
A Link Z	15-32211112	FDA UDI	Class II	Active
A Link Z	14-32211107	FDA UDI	Class II	Active
A Link Z	15-32241812	FDA UDI	Class II	Active
Align	16-18501407-SP	FDA UDI	Class II	Active
Align	16-22601307	FDA UDI	Class II	Active
Stabilis	35-18150810	FDA UDI	Class II	Active
Align	16-22451312-SP	FDA UDI	Class II	Active
Stabilis	30-14120705-SP	FDA UDI	Class II	Active
Align	16-18401012-SP	FDA UDI	Class II	Active
A Link Z	14-36261720	FDA UDI	Class II	Active
A Link Z	14-32211320	FDA UDI	Class II	Active
Align	16-22601007	FDA UDI	Class II	Active
Align	14-27271912-SP	FDA UDI	Class II	Active
Stabilis	35-14120815	FDA UDI	Class II	Active
Align	16-18400907-SP	FDA UDI	Class II	Active
Align	12-32211516	FDA UDI	Class II	Active
Align	16-22501012	FDA UDI	Class II	Active
Align	16-18400807	FDA UDI	Class II	Active
Align	14-36261512-SP	FDA UDI	Class II	Active
Align	16-18401012	FDA UDI	Class II	Active
A Link Z	10-000053	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.