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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K172975
Device Name DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional
Applicant
Synthes (USA) Products LLC/DePuy Orthopaedics Inc
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Suchitra Basu
Correspondent
Synthes (USA) Products LLC/DePuy Orthopaedics Inc
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Suchitra Basu
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received09/27/2017
Decision Date 06/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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