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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 K201959
Device Name DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
Applicant
DePuy Synthes
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact Stacey Bonnell
Correspondent
Synthes GmbH
Luzernstrasse 21
Zuchwil,  CH 4528
Correspondent Contact Georgina Mueller
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/14/2020
Decision Date 09/11/2020
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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