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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 K121323
Device Name MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE
Applicant
MEDICREA INTERNATIONAL
14 porte du grand lyon
neyron, 
Contact laure aviron-violet
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received05/02/2012
Decision Date 07/18/2012
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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