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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cerclage, fixation
510(k) Number K151848
Device Name Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
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 Number888.3010
Classification Product Code
JDQ  
Subsequent Product Code
HWC  
Date Received07/07/2015
Decision Date 01/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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