Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Remi Robotic Navigation System

K-Number: K223070 · 2022-10-28

ApplicantFusion Robotics, LLC
Decision Date2022-10-28
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Remi Robotic Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Robotics, LLC. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K223070. 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 2022-10-28. The listed applicant is Fusion Robotics, LLC. The 510(k) number is K223070.

When did Remi Robotic Navigation System receive FDA 510(k) clearance?

Remi Robotic Navigation System received FDA 510(k) clearance on 2022-10-28, under 510(k) number K223070.

Who is the listed applicant for Remi Robotic Navigation System?

The FDA 510(k) record lists Fusion Robotics, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Fusion Robotics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223350Remi Robotic Navigation System

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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.

↑