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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 K122733
Model 07.01657.XXX, 07.01658.XXX, 07.01659.XXX, 07.01660.001, 07.01661.001
Device Name V2F ANTERIOR FIXATION SYSTEM
Original Applicant
ZIMMER SPINE, INC
5301 riata park court
building f
austin,  TX  78727
Original Contact jennifer tribbett
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/11/2012
Decision Date 12/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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