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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 K233258
Device Name Shadow Knotless All-Suture Anchors
Applicant
Responsive Arthroscopy, LLC
701 N. 3rd St.
Suite 208
Minneapolis,  MN  55401
Applicant Contact Garrett Ahlborg
Correspondent
Responsive Arthroscopy, LLC
701 N. 3rd St.
Suite 208
Minneapolis,  MN  55401
Correspondent Contact Garrett Ahlborg
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/28/2023
Decision Date 10/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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