Acuity Surgical Devices, LLC
Medical device manufacturer in Irving, TX.
8510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs)OVE · Traditional | 07/30/2025SE |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs)MAX · Traditional | 06/02/2025SE |
| K243386 | Ventris Intervertebral Body Fusion DeviceOVD · Traditional | 04/22/2025SE |
| K241413 | sagAlign Lumbar Cage System (Various PNs)MAX · Traditional | 07/17/2024SE |
| K230639 | Align Cervical Interbody Fusion SystemODP · Traditional | 12/01/2023SE |
| K222561 | AlignOVD · Special | 09/23/2022SE |
| K221535 | Align Lumbar Interbody Fusion SystemMAX · Traditional | 07/22/2022SE |
| K201671 | A-Link ZOVD · Traditional | 05/04/2021SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2355-2020 Class II | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open…Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the… | 01/07/2019Open, Classified |
| Z-2354-2020 Class II | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary…Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the… | 01/07/2019Open, Classified |