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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 K121733
Device Name INFILL INTERVERTEBRAL BODY FUSION DEVICE
Original Applicant
PINNACLE SPINE GROUP, LLC
1601 elm st ste 1930
dallas,  TX  75201
Original Contact rebecca k pine
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/13/2012
Decision Date 07/13/2012
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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