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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 K100111
Device Name NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
Applicant
ZIMMER INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact ANTHONY FRANCALANICA, RAC
Correspondent
ZIMMER INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact ANTHONY FRANCALANICA, RAC
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/14/2010
Decision Date 04/12/2010
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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