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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 K212962
Device Name TRELLIS™ SI Joint Fusion System
Applicant
Orthofundamentals, LLC
173 Governors Ave.
Medford,  MA  02155
Applicant Contact Matthew Palmer
Correspondent
Orthofundamentals, LLC
8 Lookout
Hilton Head Island,  MA  29928
Correspondent Contact Howard Schrayer
Regulation Number888.3040
Classification Product Code
OUR  
Date Received09/16/2021
Decision Date 04/11/2022
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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