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FDA 510(k)

Stabilis SA Cervical Stand-Alone System (Various PNs)

K-Number: K251735 · 2025-07-30

ApplicantAcuity Surgical Devices, LLC
Decision Date2025-07-30
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stabilis SA Cervical Stand-Alone System (Various PNs) is a medical device manufactured by Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2025-07-30 under approval number K251735. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stabilis SA Cervical Stand-Alone System (Various PNs)?

Stabilis SA Cervical Stand-Alone System (Various PNs) is a medical device that received FDA 510(k) clearance on 2025-07-30. It is manufactured by Acuity Surgical Devices, LLC. The 510(k) number is K251735.

When was Stabilis SA Cervical Stand-Alone System (Various PNs) approved by the FDA?

Stabilis SA Cervical Stand-Alone System (Various PNs) received FDA 510(k) clearance on 2025-07-30, under approval number K251735.

What company makes Stabilis SA Cervical Stand-Alone System (Various PNs)?

Stabilis SA Cervical Stand-Alone System (Various PNs) is manufactured by Acuity Surgical Devices, LLC.

What is the FDA product code for Stabilis SA Cervical Stand-Alone System (Various PNs)?

The FDA product code for Stabilis SA Cervical Stand-Alone System (Various PNs) is OVE.

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Other Devices by Acuity Surgical Devices, LLC

K201671A-Link Z K222561Align K221535Align Lumbar Interbody Fusion System K230639Align Cervical Interbody Fusion System K241413sagAlign Lumbar Cage System (Various PNs) K251335Tera Lumbar Interbody Fusion System (Various PNs)

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Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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