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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 14 of 16

Device	Model / Reference	Registries	Class	Status
Stabilis	35-18151215	FDA UDI	Class II	Active
Align	16-18501512-SP	FDA UDI	Class II	Active
A Link Z	15-32211920	FDA UDI	Class II	Active
Align	16-22601707	FDA UDI	Class II	Active
Align	16-22451512	FDA UDI	Class II	Active
Stabilis	30-20161010-SP	FDA UDI	Class II	Active
A Link Z	15-32211312	FDA UDI	Class II	Active
A Link Z	14-27271107	FDA UDI	Class II	Active
Stabilis	35-18150900	FDA UDI	Class II	Active
A Link Z	15-32241307	FDA UDI	Class II	Active
Align	16-22401312	FDA UDI	Class II	Active
A Link Z	10-621136	FDA UDI	Class II	Active
Align	14-32211320-SP	FDA UDI	Class II	Active
Align	16-18451407-SP	FDA UDI	Class II	Active
Align	16-18551207	FDA UDI	Class II	Active
Align	16-22501307	FDA UDI	Class II	Active
Stabilis	35-20160505	FDA UDI	Class II	Active
Align	16-18551107	FDA UDI	Class II	Active
Stabilis	30-16140705-SP	FDA UDI	Class II	Active
Align	16-18451707-SP	FDA UDI	Class II	Active
A Link Z	15-32241007	FDA UDI	Class II	Active
A Link Z	13-368132	FDA UDI	Class II	Active
A Link Z	10-000035	FDA UDI	Class II	Active
Stabilis	35-20160805	FDA UDI	Class II	Active
Stabilis	30-20160810-SP	FDA UDI	Class II	Active
Align	16-22551512	FDA UDI	Class II	Active
Align	16-22501707	FDA UDI	Class II	Active
Stabilis	35-20161210	FDA UDI	Class II	Active
Stabilis	35-16141100	FDA UDI	Class II	Active
Align	16-22501007-SP	FDA UDI	Class II	Active
Align	14-27271712-SP	FDA UDI	Class II	Active
A Link Z	15-32211707	FDA UDI	Class II	Active
A Link Z	10-277136	FDA UDI	Class II	Active
Stabilis	30-20160910-SP	FDA UDI	Class II	Active
Align	16-22451512-SP	FDA UDI	Class II	Active
Align	16-22600907-SP	FDA UDI	Class II	Active
Align	16-18551207-SP	FDA UDI	Class II	Active
Align	16-22501307-SP	FDA UDI	Class II	Active
A Link Z	10-621157	FDA UDI	Class II	Active
A Link Z	11-328157	FDA UDI	Class II	Active
Align	16-22551507	FDA UDI	Class II	Active
A Link Z	11-328137	FDA UDI	Class II	Active
A Link Z	10-277112	FDA UDI	Class II	Active
Align	14-38301920-SP	FDA UDI	Class II	Active
Align	16-22500807	FDA UDI	Class II	Active
Align	16-22401707	FDA UDI	Class II	Active
A Link Z	11-300003	FDA UDI	Class II	Active
Align	16-22451112	FDA UDI	Class II	Active
A Link Z	16-36261312	FDA UDI	Class II	Active
A Link Z	14-27271712	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.