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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 K253695
Device Name LigaMend
Applicant
Riverpoint Medical, LLC
825 NE 25th Ave.
Portland,  OR  97272
Applicant Contact Palmira Obeso
Correspondent
Riverpoint Medical, LLC
825 NE 25th Ave.
Portland,  OR  97272
Correspondent Contact Palmira Obeso
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/21/2025
Decision Date 02/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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