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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 K120772
FOIA Releasable 510(k) K120772
Device Name NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
Applicant
Zimmer GmbH
P.O. Box 708
Warsaw,  IN  46581 -0708
Applicant Contact ROMIL SHETH
Correspondent
Zimmer GmbH
P.O. Box 708
Warsaw,  IN  46581 -0708
Correspondent Contact ROMIL SHETH
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received03/14/2012
Decision Date 06/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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