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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K213768
Device Name Bolt Navigation System
Applicant
Circinus Medical Technology, LLC
4450 Arapahoe Ave., Suite 1000
Boulder,  CO  80303
Applicant Contact Patrick West
Correspondent
Mcra, LLC
803 7th St. NW, 3rd Floor
Washington,  DC  20001
Correspondent Contact Alex Cadotte
Regulation Number892.1650
Classification Product Code
OWB  
Date Received12/01/2021
Decision Date 12/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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