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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
Original Applicant
MEDICREA INTERNATIONAL
14 porte du grand lyon
neyron,  FR 01700
Original 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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