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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 K211051
Device Name DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
Applicant
DePuy Synthes
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact Stacey Bonnell
Correspondent
DePuy Synthes
Luzernstrasse 21
Zuchwil,  CH 4528
Correspondent Contact Ann-Christin Ponick
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/08/2021
Decision Date 06/02/2021
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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