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

FDA 510(k)

Bolt Navigation System

K-Number: K213768 · 2022-12-01

ApplicantCircinus Medical Technology, LLC
Decision Date2022-12-01
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bolt Navigation System is a medical device manufactured by Circinus Medical Technology, LLC. It received FDA 510(k) clearance on 2022-12-01 under approval number K213768. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bolt Navigation System?

Bolt Navigation System is a medical device that received FDA 510(k) clearance on 2022-12-01. It is manufactured by Circinus Medical Technology, LLC. The 510(k) number is K213768.

When was Bolt Navigation System approved by the FDA?

Bolt Navigation System received FDA 510(k) clearance on 2022-12-01, under approval number K213768.

What company makes Bolt Navigation System?

Bolt Navigation System is manufactured by Circinus Medical Technology, LLC.

What is the FDA product code for Bolt Navigation System?

The FDA product code for Bolt Navigation System is OWB.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT06895187 Catheter Ablation Using a Novel Navigation and Imaging System NOT_YET_RECRUITING

Related PubMed Literature

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)

Related Devices (Code: OWB)

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. K162148Allura Xper R9Philips Medical Systems Nethrlands BV K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. K161976Ziehm Solo FDZiehm Imaging GmbH K161756SyncVision SystemVolcano Corporation

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.

↑