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 spinous process plate
510(k) Number K201704
Device Name CoFix System
Applicant
Paradigm Spine GmbH
375 River Park Circle
Marquette,  MI  49855
Applicant Contact Branko Sostarko
Correspondent
MCRA, LLC
1050 K Street NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3050
Classification Product Code
PEK  
Date Received06/22/2020
Decision Date 08/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-