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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pin, fixation, smooth
510(k) Number K171715
Device Name HammerTube System
Paragon 28
4B Inverness Ct. E., STE 280
Englewood,  CO  80112
Applicant Contact Frank S. Bono
BackRoads Consulting, Inc
PO Box 566
Chesterland,  OH  44026 -0566
Correspondent Contact Karen E. Warden
Regulation Number888.3040
Classification Product Code
Date Received06/09/2017
Decision Date 03/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls