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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 K232211
Device Name REUNION Sacroiliac Joint Fusion System
Applicant
Astura Medical
4949 W. Royal Ln
Irving,  TX  75063
Applicant Contact Parker Kelch
Correspondent
Astura Medical
4949 W. Royal Ln
Irving,  TX  75063
Correspondent Contact Parker Kelch
Regulation Number888.3040
Classification Product Code
OUR  
Date Received07/26/2023
Decision Date 10/24/2023
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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