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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 K081759
Device Name NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V
Applicant
ZIMMER GMBH
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact ERIC S PITTMAN
Correspondent
ZIMMER GMBH
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact ERIC S PITTMAN
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/20/2008
Decision Date 10/16/2008
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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