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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 K211496
Device Name TransLoc 3D
Applicant
Foundation Fusion Solutions, LLC (Dba Cornerloc)
11916 S. Oxford Ave., Suite 206
Tulsa,  OK  74137
Applicant Contact Robert Compton
Correspondent
Watershed Idea Foundry
1815 Aston Ave., Suite 106
Carlsbad,  CA  92008
Correspondent Contact Jeffrey Brittan
Regulation Number888.3040
Classification Product Code
OUR  
Date Received05/13/2021
Decision Date 07/27/2022
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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