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FDA 510(k)

ARAI Surgical Navigation System

K-Number: K211254 · 2022-01-14

ApplicantSurgalign Spine Technologies
Decision Date2022-01-14
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ARAI Surgical Navigation System is a medical device manufactured by Surgalign Spine Technologies. It received FDA 510(k) clearance on 2022-01-14 under approval number K211254. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARAI Surgical Navigation System?

ARAI Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2022-01-14. It is manufactured by Surgalign Spine Technologies. The 510(k) number is K211254.

When was ARAI Surgical Navigation System approved by the FDA?

ARAI Surgical Navigation System received FDA 510(k) clearance on 2022-01-14, under approval number K211254.

What company makes ARAI Surgical Navigation System?

ARAI Surgical Navigation System is manufactured by Surgalign Spine Technologies.

What is the FDA product code for ARAI Surgical Navigation System?

The FDA product code for ARAI Surgical Navigation System is SBF.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42184430 Navigation-guided endoscopic transcerebellar approach for cyst fenestration of a dorsal brainstem lesion: illustrative case. Journal of neurosurgery. Case lessons (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Surgalign Spine Technologies

K221403Cortera Spinal Fixation System K231611HOLO Portal™ Surgical Guidance System

Related Devices (Code: SBF)

K190929xvision Spine system (XVS)Augmedics, Ltd. K202152NextAR TKA PlatformMedacta International S.A. K193559NextAR TKA PlatformMedacta Inernational SA K210859NextAR™ Spine PlatformMedacta International S.A. K211188xvision Spine system (XVS)Augmedics, Ltd. K210153NextAR RSA PlatformMedacta International S.A.

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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