Company ยท US
Acuity Surgical Devices, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 2025 | K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) Acuity Surgical Devices, LLC | OVE |
| Jun 2, 2025 | K251335 | Tera Lumbar Interbody Fusion System (Various PNs) Acuity Surgical Devices, LLC | MAX |
| Apr 22, 2025 | K243386 | Ventris Intervertebral Body Fusion Device Acuity Surgical Devices, LLC | OVD |
| Jul 17, 2024 | K241413 | sagAlign Lumbar Cage System (Various PNs) Acuity Surgical Devices, LLC | MAX |
| Dec 1, 2023 | K230639 | Align Cervical Interbody Fusion System Acuity Surgical Devices, LLC | ODP |
| Sep 23, 2022 | K222561 | Align Acuity Surgical Devices, LLC | OVD |
| Jul 22, 2022 | K221535 | Align Lumbar Interbody Fusion System Acuity Surgical Devices, LLC | MAX |
| May 4, 2021 | K201671 | A-Link Z Acuity Surgical Devices, LLC | OVD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2019 | Acuity Surgical Devices, LLC 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 32x24x1 Open, Classified |
OVD | K133827 |
| Jan 7, 2019 | Acuity Surgical Devices, LLC 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 Open, Classified |
OVD | K133827 |