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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, spinal intervertebral body
510(k) Number K140611
Device Name TRINICA ANTERIOR LUMBAR PLATE SYSTEM
Original Applicant
ZIMMER SPINE, INC.
7375 bush lake rd
minneapolis,  MN  55439
Original Contact donna m semlak
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/10/2014
Decision Date 05/21/2014
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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