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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K180310
Device Name DePuy Synthes Trauma Orthopedic Plates and Screws
Applicant
Synthes (USA) Products LLC/DePuy Orthopaedics Inc
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Jeffrey Krawiec
Correspondent
Synthes (USA) Products LLC/DePuy Orthopaedics Inc
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Jeffrey Krawiec
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   KTT   KTW   LXT  
Date Received02/05/2018
Decision Date 11/01/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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