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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinous Process Plate
510(k) Number K201704
Device Name CoFix System
Applicant
Paradigm Spine GmbH
375 River Park Cir.
Marquette,  MI  49855
Applicant Contact Branko Sostarko
Correspondent
Mcra, LLC
1050 K. St. 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
Predetermined Change
Control Plan Authorized		 No
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