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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 K251365
Device Name OptumSI Implant System
Applicant
Si Solutions, LLC
1010 Club Village Dr. Suite C
Columbia,  MO  62503
Applicant Contact Craig Meyer
Correspondent
Engineer Aid
1384 Dallas Cir. SW
Marietta,  GA  30064
Correspondent Contact Austin Howell
Regulation Number888.3040
Classification Product Code
OUR  
Date Received05/01/2025
Decision Date 11/20/2025
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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