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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K243988
Device Name RootMend MRR
Applicant
Riverpoint Medical, LLC
825 NE 25th Ave.
Portland,  OR  97272
Applicant Contact Jacquelyn Pinnel
Correspondent
Riverpoint Medical, LLC
825 NE 25th Ave.
Portland,  OR  97272
Correspondent Contact Edwin Anderson Anderson
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HTN  
Date Received12/26/2024
Decision Date 03/20/2025
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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