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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 K150099
Device Name Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)
Applicant
SYNTHES (USA) PRODUCTS, LLC
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Applicant Contact NICHOLAS FOUNTOULAKIS
Correspondent
SYNTHES (USA) PRODUCTS, LLC
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Correspondent Contact NICHOLAS FOUNTOULAKIS
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/20/2015
Decision Date 03/23/2015
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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