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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 K232259
Device Name Patriot-SI Posterior Implant System
Applicant
Spinal Simplicity, LLC
6363 College Blvd.
Suite 320
Overland Park,  KS  66211
Applicant Contact Adam Rogers
Correspondent
Spinal Simplicity, LLC
6363 College Blvd.
Suite 320
Overland Park,  KS  66211
Correspondent Contact Adam Rogers
Regulation Number888.3040
Classification Product Code
OUR  
Date Received07/31/2023
Decision Date 04/19/2024
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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