# Acuity Surgical Devices, LLC

- Location (FDA's records): Irving, TX
- FDA decisions: 8 (2021–2025): 8 510(k) clearances
- Product codes: MAX (3), OVD (3), ODP (1), OVE (1)
- 510(k) review time since 2016: median 59 days, against 103 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 22 (9 its own); citations of its devices by later devices: 16 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aurora Spine, Inc.: 2 (https://510kreport.com/company/aurora-spine)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Osteo Vasive, LLC: 1 (https://510kreport.com/company/osteo-vasive)
- Spinal Elements, Inc.: 1 (https://510kreport.com/company/spinal-elements)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Choicespine, LP: 1 (https://510kreport.com/company/choicespine)
- Corelink, LLC: 1 (https://510kreport.com/company/corelink)

## Firms that cite its devices most
- C.A. Medical, LLC: 2 (https://510kreport.com/company/ca-medical)
- SeaSpine Orthopedics Corporation: 1 (https://510kreport.com/company/seaspine-orthopedics)
- Novapproach Spine: 1 (https://510kreport.com/company/novapproach-spine)
- Aurora Spine, Inc.: 1 (https://510kreport.com/company/aurora-spine)
- Next Orthosurgical: 1 (https://510kreport.com/company/next-orthosurgical)
- Evolution Spine: 1 (https://510kreport.com/company/evolution-spine)

## Its most-cited devices
- K201671: A-Link Z (2021), cited by 5
- K222561: Align (2022), cited by 5
- K221535: Align Lumbar Interbody Fusion System (2022), cited by 2
- K251335: Tera Lumbar Interbody Fusion System (Various PNs) (2025), cited by 1
- K230639: Align Cervical Interbody Fusion System (2023), cited by 1
- K243386: Ventris Intervertebral Body Fusion Device (2025), cited by 1

## Recent decisions
- K251735: Stabilis SA Cervical Stand-Alone System (Various PNs) (Jul 30, 2025)
- K251335: Tera Lumbar Interbody Fusion System (Various PNs) (Jun 2, 2025)
- K243386: Ventris Intervertebral Body Fusion Device (Apr 22, 2025)
- K241413: sagAlign Lumbar Cage System (Various PNs) (Jul 17, 2024)
- K230639: Align Cervical Interbody Fusion System (Dec 1, 2023)
- K222561: Align (Sep 23, 2022)
- K221535: Align Lumbar Interbody Fusion System (Jul 22, 2022)
- K201671: A-Link Z (May 4, 2021)

Source page: https://510kreport.com/company/acuity-surgical-devices