ARAI Surgical Navigation System

Q: What is the product code of K211254?

The FDA product code is SBF – Orthopedic Augmented Reality, a Class II (moderate risk) device regulated under 21 CFR 882.4560.

FDA 510(k) K211254 · Surgalign Spine Technologies

Substantially Equivalent

510(k) numberK211254

Submission

Device name: ARAI Surgical Navigation System
Applicant: Surgalign Spine Technologies
Deerfield, IL, US
Received: April 26, 2021
Decision date: January 14, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: SBF – Orthopedic Augmented Reality
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4560
Specialty: Neurology

An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as augmented reality stereoscopic images to intraoperatively augment the users field of view.

Other 510(k)s with product code SBF

510(k)	Device	Applicant	Decision
K261854	xvision Spine systemSBF · Traditional	Augmedics, Ltd.	07/31/2026SE
K253805	Knee+SBF · Traditional	Pixee Medical S.A.S.	04/24/2026SE
K252847	NextAR Hip PlatformSBF · Traditional	Medacta International S.A.	01/09/2026SE
K251639	xvision Spine systemSBF · Traditional	Augmedics, Ltd.	10/03/2025SE
K252054	SpineAR SNAP (SyncAR Spine)SBF · Traditional	Surgical Theater, Inc.	09/29/2025SE
K252530	OptiVu ShoulderSBF · Special	Mr Surgical Solutions, LLC	09/10/2025SE
K251737	NextAR(TM) Shoulder PlatformSBF · Traditional	Medacta International S.A.	09/04/2025SE
K252170	OptiVu ShoulderSBF · Special	Mr Surgical Solutions, LLC	08/08/2025SE
K250477	NextAR(TM) SpineSBF · Traditional	Medacta International S.A.	07/31/2025SE
K250108	OptiVu ShoulderSBF · Traditional	Mr Surgical Solutions, LLC	07/09/2025SE

510(k)	Device	Decision
K231611	HOLO Portal Surgical Guidance SystemSBF · Traditional	08/31/2023SE
K221403	Cortera Spinal Fixation SystemNKB · Traditional	08/19/2022SE

Questions and answers

When was ARAI Surgical Navigation System cleared by the FDA?

ARAI Surgical Navigation System (K211254) received a 510(k) decision of Substantially Equivalent on January 14, 2022, 263 days after the submission was received.

What is the product code of K211254?

The FDA product code is SBF – Orthopedic Augmented Reality, a Class II (moderate risk) device regulated under 21 CFR 882.4560.