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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, cervical
510(K) Number K122008
Device Name INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
Applicant
INCITE INNOVATION LLC
1500 main street
ste. 2410
springfield,  MA  01115
Contact john kirwan
Regulation Number888.3080
Classification Product Code
OVE  
Date Received07/09/2012
Decision Date 11/16/2012
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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