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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 K160553
Device Name DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S
Applicant
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact ELIZABETH JACOBS
Correspondent
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact ELIZABETH JACOBS
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HSB   HTY   HWC   JDS   KTT  
KTW   LXT  
Date Received02/29/2016
Decision Date 06/30/2017
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
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