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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 bone graft, lumbar
510(K) Number K120368
Device Name CAPSTONE CONTROL SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis,  TN  38132
Contact julie bassett
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/06/2012
Decision Date 04/09/2012
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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