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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 K172157
Device Name DePuy Synthes Femoral Recon Nail System
Applicant
Synthes (USA) Products, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Alexander Zwahlen
Correspondent
Synthes (USA) Products, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Alexander Zwahlen
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/18/2017
Decision Date 11/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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