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FDA 510(k)

Remi Robotic Navigation System

K-Number: K223350 · 2023-03-13

ApplicantFusion Robotics, LLC
Decision Date2023-03-13
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Remi Robotic Navigation System is a medical device manufactured by Fusion Robotics, LLC. It received FDA 510(k) clearance on 2023-03-13 under approval number K223350. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Remi Robotic Navigation System?

Remi Robotic Navigation System is a medical device that received FDA 510(k) clearance on 2023-03-13. It is manufactured by Fusion Robotics, LLC. The 510(k) number is K223350.

When was Remi Robotic Navigation System approved by the FDA?

Remi Robotic Navigation System received FDA 510(k) clearance on 2023-03-13, under approval number K223350.

What company makes Remi Robotic Navigation System?

Remi Robotic Navigation System is manufactured by Fusion Robotics, LLC.

What is the FDA product code for Remi Robotic Navigation System?

The FDA product code for Remi Robotic Navigation System is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING NCT07606963 Triton 1.5 Robotic System for Diagnostic Colonoscopy NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED

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: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (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 Fusion Robotics, LLC

K223070Remi Robotic Navigation System

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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