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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with integrated fixation, lumbar
510(k) Number K120557
Device Name SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35
Original Applicant
BIOMET SPINE & BONE HEALING TECHNOLOGIES
100 interpace parkway
parsippany,  NJ  07054
Original Contact margaret f crowe
Regulation Number888.3080
Classification Product Code
OVD  
Date Received02/24/2012
Decision Date 03/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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