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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K232149
Device Name BowTie™ SI Joint Fusion System
Applicant
Sail Fusion, LLC
2010 Jimmy Durante Blvd., Suite 200
Del Mar,  CA  92014
Applicant Contact Benjamin Arnold
Correspondent
Sail Fusion, LLC
2010 Jimmy Durante Blvd., Suite 200
Del Mar,  CA  92014
Correspondent Contact Benjamin Arnold
Regulation Number888.3040
Classification Product Code
OUR  
Date Received07/19/2023
Decision Date 04/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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