Acuity Surgical Devices, LLC
Irving, TX, US
ACUITY SURGICAL DEVICES, LLC appears in FDA device records in Irving, TX. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Acuity Surgical Devices, LLC between 2021 and 2025. The busiest year on record is 2025, with 3. The most recent is 2025, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | OVE | Substantially Equivalent | |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | MAX | Substantially Equivalent | |
| K243386 | Ventris Intervertebral Body Fusion Device | OVD | Substantially Equivalent | |
| K241413 | sagAlign Lumbar Cage System (Various PNs) | MAX | Substantially Equivalent | |
| K230639 | Align Cervical Interbody Fusion System | ODP | Substantially Equivalent | |
| K222561 | Align | OVD | Substantially Equivalent | |
| K221535 | Align Lumbar Interbody Fusion System | MAX | Substantially Equivalent | |
| K201671 | A-Link Z | OVD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010866843 | 3010866843 | ACUITY SURGICAL DEVICES, LLC | 8710 N Royal Lane, Irving, TX 75063 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2355-2020 | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion. | Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage. | Class II | Open, Classified | |
| Z-2354-2020 | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x17 12 A Link Z Ti Unitary Plate-Cage 32x21x17 16 A Link Z Ti Unitary Plate-Cage 32x21x17 20 A Link Z Ti Unitary Plate-Cage 32x21x19 20 A Link Z Ti Unitary Plate-Cage 32x24x15 7 A Link Z Ti Unitary Plate-Cage 32x24x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 12 A Link Z Ti Unitary Plate-Cage 36x26x15 12 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion. | Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain