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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K192745
Device Name DePuy Synthes Trauma Screws
Applicant
Synthes (USA) Products LLC / DePuy Orthopaedics Inc
1301 Goshen Parkway
west chester,  PA  19380
Applicant Contact keith knapp
Correspondent
Synthes (USA) Products LLC / DePuy Orthopaedics Inc
1301 Goshen Parkway
west chester,  PA  19380
Correspondent Contact keith knapp
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
HRS   HTN   HTY   JDS   JDW  
KTT   NDG  
Date Received09/30/2019
Decision Date 11/26/2019
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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