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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 K123918
Device Name MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
Applicant
Zimmer, Inc.
345 E. Main St.
Warsaw,  IN  46580
Applicant Contact STEPHEN H MCKELVEY, MA, RAC
Correspondent
Zimmer, Inc.
345 E. Main St.
Warsaw,  IN  46580
Correspondent Contact STEPHEN H MCKELVEY, MA, RAC
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/19/2012
Decision Date 02/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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