Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K203121
Device Name Responsive Arthroscopy Thunderbolt System
Applicant
Responsive Arthroscopy, LLC
701 N. 3rd St.
Suite 208
Minneapolis,  MN  55401
Applicant Contact Douglas Kohrs
Correspondent
Cor Medical Ventures, Inc.
2010 Jimmy Durante Blvd., Suite 200
Del Mar,  CA  92014
Correspondent Contact Benjamin Arnold
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
JDR  
Date Received10/16/2020
Decision Date 04/27/2021
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
-
-