Acuity Surgical Devices, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Acuity Surgical Devices, LLC” (first 2021, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 58 days. Since 2017 the median was 58 days, against 107 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 319 |
| 2022 | 2 | 43 |
| 2023 | 1 | 268 |
| 2024 | 1 | 61 |
| 2025 | 3 | 54 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Acuity Surgical Devices, LLC took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Acuity Surgical Devices, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | OVE | 2025-07-30 | 54 |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | MAX | 2025-06-02 | 33 |
| K243386 | Ventris Intervertebral Body Fusion Device | OVD | 2025-04-22 | 173 |
| K241413 | sagAlign Lumbar Cage System (Various PNs) | MAX | 2024-07-17 | 61 |
| K230639 | Align Cervical Interbody Fusion System | ODP | 2023-12-01 | 268 |
| K222561 | Align | OVD | 2022-09-23 | 30 |
| K221535 | Align Lumbar Interbody Fusion System | MAX | 2022-07-22 | 56 |
| K201671 | A-Link Z | OVD | 2021-05-04 | 319 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-01-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Acuity Polymers, Inc. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acuity Surgical Devices, LLC?
FDA lists 8 510(k) clearances under the applicant name “Acuity Surgical Devices, LLC” (first 2021, latest 2025), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Acuity Surgical Devices, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acuity Surgical Devices, LLC is 58 days. Since 2017: 58 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Acuity Surgical Devices, LLC?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 3); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 1).
Next steps
- See all 8 Acuity Surgical Devices, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Acuity Surgical Devices, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.