Acuity Surgical Devices, LLC
FDA Regulatory Profile
Acuity Surgical Devices, LLC appears in FDA public data with 2 recalls, 8 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2355-2020, Class II) was initiated on January 7, 2019. Its most recent 510(k) clearance was granted on July 30, 2025.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 8
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2355-2020 | Class II | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbo | January 7, 2019 |
| Z-2354-2020 | Class II | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 3 | January 7, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | July 30, 2025 |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | June 2, 2025 |
| K243386 | Ventris Intervertebral Body Fusion Device | April 22, 2025 |
| K241413 | sagAlign Lumbar Cage System (Various PNs) | July 17, 2024 |
| K230639 | Align Cervical Interbody Fusion System | December 1, 2023 |
| K222561 | Align | September 23, 2022 |
| K221535 | Align Lumbar Interbody Fusion System | July 22, 2022 |
| K201671 | A-Link Z | May 4, 2021 |