Cleared Traditional

Stabilis SA Cervical Stand-Alone System (Various PNs)

K251735 · Acuity Surgical Devices, LLC · Orthopedic

Jul 2025

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K251735 is an FDA 510(k) clearance for the Stabilis SA Cervical Stand-Alone System (Various PNs), a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Acuity Surgical Devices, LLC (Irving, US). The FDA issued a Cleared decision on July 30, 2025, 54 days after receiving the submission on June 6, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K251735 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2025
Decision Date	July 30, 2025
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.