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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
510(k) Number K170693
Device Name Phantom Small Bone Intramedullary Nail System
Applicant
Paragon 28, Inc.
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
Regulation Number888.3030
Classification Product Code
KTW  
Subsequent Product Code
HWC  
Date Received03/07/2017
Decision Date 06/19/2017
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
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