Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Acuity Surgical Devices with 8 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Jul 30, 2025: Stabilis SA Cervical Stand-Alone System (Various PNs).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 30, 2025 | Stabilis SA Cervical Stand-Alone System (Various PNs)K251735 · OVE | 510(k) clearances |
| Jun 2, 2025 | Tera Lumbar Interbody Fusion System (Various PNs)K251335 · MAX | 510(k) clearances |
| Apr 22, 2025 | Ventris Intervertebral Body Fusion DeviceK243386 · OVD | 510(k) clearances |
| Jul 17, 2024 | sagAlign Lumbar Cage System (Various PNs)K241413 · MAX | 510(k) clearances |
| Dec 1, 2023 | Align Cervical Interbody Fusion SystemK230639 · ODP | 510(k) clearances |
| Sep 23, 2022 | AlignK222561 · OVD | 510(k) clearances |
| Jul 22, 2022 | Align Lumbar Interbody Fusion SystemK221535 · MAX | 510(k) clearances |
| May 4, 2021 | A-Link ZK201671 · OVD | 510(k) clearances |
| Jan 7, 2019 | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Class II · Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal devic | Device recalls |
| Jan 7, 2019 | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-CagClass II · Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal devic | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
