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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K192163
Device Name TTC Phantom® Intramedullary Nail System
Applicant
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Applicant Contact Haylie Hertz
Correspondent
Paragon 28, Inc.
1445 Grasslands Dr.
Englewood,  CO  80112
Correspondent Contact Haylie Hertz
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received08/09/2019
Decision Date 01/31/2020
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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