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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 9 of 16

Device	Model / Reference	Registries	Class	Status
Stabilis	35-14120705	FDA UDI	Class II	Active
Align	16-22451007-SP	FDA UDI	Class II	Active
Align	14-32211107-SP	FDA UDI	Class II	Active
Stabilis	35-18151110	FDA UDI	Class II	Active
Stabilis	30-16141005-SP	FDA UDI	Class II	Active
Align	14-50000001	FDA UDI	Class II	Active
A Link Z	15-32241212	FDA UDI	Class II	Active
Stabilis	35-14120700	FDA UDI	Class II	Active
Stabilis	35-16140600	FDA UDI	Class II	Active
Align	16-18501112	FDA UDI	Class II	Active
Align	14-32211516-SP	FDA UDI	Class II	Active
Align	16-22500912-SP	FDA UDI	Class II	Active
A Link Z	16-28100907	FDA UDI	Class II	Active
Align	16-22501112-SP	FDA UDI	Class II	Active
A Link Z	10-277156	FDA UDI	Class II	Active
A Link Z	15-32211520	FDA UDI	Class II	Active
Align	16-22451712-SP	FDA UDI	Class II	Active
Stabilis	30-16141215-SP	FDA UDI	Class II	Active
Stabilis	35-18150605	FDA UDI	Class II	Active
Align	16-18450907-SP	FDA UDI	Class II	Active
Stabilis	35-20160605	FDA UDI	Class II	Active
Stabilis	35-16140505	FDA UDI	Class II	Active
Align	16-22451507	FDA UDI	Class II	Active
A Link Z	15-32241712	FDA UDI	Class II	Active
A Link Z	10-621152	FDA UDI	Class II	Active
Stabilis	30-16140710-SP	FDA UDI	Class II	Active
Stabilis	35-14121215	FDA UDI	Class II	Active
A Link Z	10-621170	FDA UDI	Class II	Active
Stabilis	30-16141010-SP	FDA UDI	Class II	Active
A Link Z	15-32241612	FDA UDI	Class II	Active
A Link Z	11-002550	FDA UDI	Class II	Active
A Link Z	11-360003	FDA UDI	Class II	Active
Align	16-18451207-SP	FDA UDI	Class II	Active
A Link Z	14-38301107	FDA UDI	Class II	Active
Stabilis	35-20161105	FDA UDI	Class II	Active
A Link Z	14-36261112	FDA UDI	Class II	Active
Align	16-18401007	FDA UDI	Class II	Active
Align	16-18500907-SP	FDA UDI	Class II	Active
Stabilis	35-20161115	FDA UDI	Class II	Active
Stabilis	35-14121105	FDA UDI	Class II	Active
Stabilis	30-16140910-SP	FDA UDI	Class II	Active
Align	16-22501512	FDA UDI	Class II	Active
Stabilis	30-14121205-SP	FDA UDI	Class II	Active
Align	16-22551012	FDA UDI	Class II	Active
Align	14-27271312-SP	FDA UDI	Class II	Active
Stabilis	35-14121000	FDA UDI	Class II	Active
A Link Z	16-28100807	FDA UDI	Class II	Active
A Link Z	10-277092	FDA UDI	Class II	Active
Align	16-18501012-SP	FDA UDI	Class II	Active
Align	14-38301307-SP	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.