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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 7 of 16

Device	Model / Reference	Registries	Class	Status
Align	16-22551707	FDA UDI	Class II	Active
Align	14-32211316-SP	FDA UDI	Class II	Active
Stabilis	30-16140805-SP	FDA UDI	Class II	Active
Align	16-22450907	FDA UDI	Class II	Active
Align	14-27271507-SP	FDA UDI	Class II	Active
A Link Z	15-32241507	FDA UDI	Class II	Active
Align	16-18550812	FDA UDI	Class II	Active
A Link Z	14-27271412	FDA UDI	Class II	Active
Stabilis	30-20160705-SP	FDA UDI	Class II	Active
Align	35-50000001-3	FDA UDI	Class II	Active
A Link Z	10-000041	FDA UDI	Class II	Active
Align	16-18451707	FDA UDI	Class II	Active
Align	14-36261707-SP	FDA UDI	Class II	Active
Stabilis	30-14121110-SP	FDA UDI	Class II	Active
A Link Z	14-27271312	FDA UDI	Class II	Active
A Link Z	11-328152	FDA UDI	Class II	Active
A Link Z	13-328132	FDA UDI	Class II	Active
Align	16-22401712	FDA UDI	Class II	Active
Stabilis	35-14120910	FDA UDI	Class II	Active
Stabilis	35-20161000	FDA UDI	Class II	Active
Align	16-22451012	FDA UDI	Class II	Active
Align	16-18401507-SP	FDA UDI	Class II	Active
Align	16-18551407	FDA UDI	Class II	Active
Align	16-18550807	FDA UDI	Class II	Active
Align	16-22451707-SP	FDA UDI	Class II	Active
Align	16-18501707	FDA UDI	Class II	Active
A Link Z	14-27271612	FDA UDI	Class II	Active
Stabilis	35-18151100	FDA UDI	Class II	Active
A Link Z	15-32241412	FDA UDI	Class II	Active
Stabilis	30-16140505-SP	FDA UDI	Class II	Active
Align	16-22500907-SP	FDA UDI	Class II	Active
Stabilis	35-14120915	FDA UDI	Class II	Active
Stabilis	35-14121115	FDA UDI	Class II	Active
Align	16-22501712	FDA UDI	Class II	Active
Stabilis	35-18150815	FDA UDI	Class II	Active
Align	16-22550812-SP	FDA UDI	Class II	Active
Align	14-32211112-SP	FDA UDI	Class II	Active
Align	16-22601312-SP	FDA UDI	Class II	Active
Stabilis	30-18150505-SP	FDA UDI	Class II	Active
Align	16-22601312	FDA UDI	Class II	Active
Stabilis	35-20161015	FDA UDI	Class II	Active
Align	14-36261520-SP	FDA UDI	Class II	Active
A Link Z	10-277177	FDA UDI	Class II	Active
Align	11-102050-SP	FDA UDI	Class II	Active
Stabilis	35-20160705	FDA UDI	Class II	Active
A Link Z	13-368157	FDA UDI	Class II	Active
A Link Z	14-27271007	FDA UDI	Class II	Active
Stabilis	35-20161100	FDA UDI	Class II	Active
Stabilis	35-14121100	FDA UDI	Class II	Active
Align	16-18401507	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.