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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 K120991
Device Name TRANS1 INTERBODY FUSION SYSTEM
Applicant
TRANS1 INCORPORATED
301 government center dr suite 100
wilmington,  NC  28403
Contact cheryl l wagoner
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/02/2012
Decision Date 08/23/2012
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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