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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K202569
Device Name Responsive Arthroscopy Interference Screw System
Applicant
Responsive Arthroscopy, LLC
701 N. 3rd St.
Suite 208
Minneapolis,  MN  55401
Applicant Contact Douglas Kohrs
Correspondent
Cor Medical Ventures
215 S. Hwy. 101
Suite 200
Solana Beach,  CA  92075
Correspondent Contact Kristen Pena
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MBI  
Date Received09/04/2020
Decision Date 09/23/2020
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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