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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K170923
Device Name JAWS(TM) Nitinol Staple 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 -0566
Correspondent Contact Karen E. Warden
Regulation Number888.3030
Classification Product Code
JDR  
Date Received03/29/2017
Decision Date 07/24/2017
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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