Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Acuity Surgical Devices, LLC · Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

61 daysmedian FDA review time
319 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC2025-07-30540
K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC2025-06-02330
K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC2025-04-221730
K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC2024-07-17610
K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC2023-12-012680
K222561AlignAcuity Surgical Devices, LLC2022-09-23300
K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC2022-07-22560
K201671A-Link ZAcuity Surgical Devices, LLC2021-05-043190

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda