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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 K180951
Device Name Responsive Arthroscopy Suture Anchor System
Applicant
Responsive Arthroscopy, LLC
701 N. 3rd St., Suite 202
Minneapolis,  MN  55401
Applicant Contact Doug Kohrs
Correspondent
Cor Medical Ventures, LLC
215 S. Hwy. 101
Suite 200
Solana Beach,  CA  92075
Correspondent Contact Benjamin Arnold
Regulation Number888.3040
Classification Product Code
MBI  
Date Received04/11/2018
Decision Date 01/03/2019
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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