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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 K113527
Device Name OPTICAGE INTERBODY FUSION DEVICE
Original Applicant
INTERVENTIONAL SPINE, INC.
13700 alton pkwy., suite 160
irvine,  CA  92618
Original Contact jane metcalf
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/30/2011
Decision Date 01/20/2012
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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