Medical Device Manufacturer · US , Irving , TX

Acuity Surgical Devices, LLC - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2021
8
Total
8
Cleared
0
Denied

Acuity Surgical Devices, LLC has 8 FDA 510(k) cleared medical devices. Based in Irving, US.

Latest FDA clearance: Jul 2025. Active since 2021. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by Acuity Surgical Devices, LLC Filter by specialty or product code using the sidebar.

8 devices
1–8 of 8
Stabilis SA Cervical Stand-Alone System (Various PNs)
K251735 · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical · Orthopedic
Jul 2025 54d
Tera Lumbar Interbody Fusion System (Various PNs)
K251335 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar · Orthopedic
Jun 2025 33d
Ventris Intervertebral Body Fusion Device
K243386 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar · Orthopedic
Apr 2025 173d
sagAlign Lumbar Cage System (Various PNs)
K241413 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar · Orthopedic
Jul 2024 61d
Align Cervical Interbody Fusion System
K230639 · ODP Intervertebral Fusion Device With Bone Graft, Cervical · Orthopedic
Dec 2023 268d
Align
K222561 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar · Orthopedic
Sep 2022 30d
Align Lumbar Interbody Fusion System
K221535 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar · Orthopedic
Jul 2022 56d
A-Link Z
K201671 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar · Orthopedic
May 2021 319d
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