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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 K150121
Device Name Zimmer Periarticular Plating System
P.O.BOX 708
warsaw,  IN  46581 -0708
Applicant Contact patrick mccullagh
P.O.BOX 708
warsaw,  IN  46581 -0708
Correspondent Contact stephen h mckelvey
Regulation Number888.3030
Classification Product Code
Date Received01/20/2015
Decision Date 02/23/2015
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