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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 interlaminal
510(k) Number K121136
Device Name RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
Original Applicant
ACCEL SPINE
14850 quorum dr ste 220
dallas,  TX  75254
Original Contact daniel chon
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received05/21/2012
Decision Date 08/09/2012
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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