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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 K120070
Device Name SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
Applicant
SYNTHES USA
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Applicant Contact ANGELA F LASSANDRO
Correspondent
SYNTHES USA
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Correspondent Contact ANGELA F LASSANDRO
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/09/2012
Decision Date 03/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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