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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 K203740
Device Name JuggerKnot Soft Anchor
Applicant
Riverpoint Medical
825 NE 25th Ave.
Portland,  OR  97232
Applicant Contact Amanda Cole
Correspondent
Riverpoint Medical
825 NE 25th Ave.
Portland,  OR  97232
Correspondent Contact Amanda Cole
Regulation Number888.3040
Classification Product Code
MBI  
Date Received12/22/2020
Decision Date 02/12/2021
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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