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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, nail/blade/plate combination, multiple component
510(k) Number K151907
Device Name Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46580
Applicant Contact PATRICK MCCULLAGH
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46580
Correspondent Contact DALENE BINKLEY
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDQ  
Date Received07/13/2015
Decision Date 12/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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