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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K130810
Device Name ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
Applicant
ZIMMER, INC.
9001 WESLEYAN ROAD, STE 200
INDIANAPOLIS,  IN  46268
Applicant Contact SCOTT M DURLACHER
Correspondent
ZIMMER, INC.
9001 WESLEYAN ROAD, STE 200
INDIANAPOLIS,  IN  46268
Correspondent Contact SCOTT M DURLACHER
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/25/2013
Decision Date 09/19/2013
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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