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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Wedge
510(k) Number K162241
Device Name TITAN 3-D™ Wedge System
Applicant
Paragon 28
4b Inverness Ct. E, Suite 280
Englewood,  CO  80112
Applicant Contact Frank S. Bono
Correspondent
Backroads Consulting, Inc.
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden, Ph.D.
Regulation Number888.3030
Classification Product Code
PLF  
Subsequent Product Code
HWC  
Date Received08/10/2016
Decision Date 04/03/2017
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
Recalls CDRH Recalls
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