Internet address htp/wwfagvMdcleie/eorefro/nutydfuthm Sincerely / modification subject device / nmedical device / announcements concerning your device / intervertebral body fusion device / body fusion device / predicate device / rod systems / supplemental fixation systems / manufacturing practice requirements / marketed predicate devices / manufacturing practice / rods systems / supplemental spinal fixation systems / /
MedicalCondition
degenerative disc disease / Deficiency / back pain / I Spondylolisthesis / /
MedicalTreatment
spinal surgery / /
Organization
Division of Postmarket Surveillance / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic and Restorative Devices Office / Mark N. Melkerson Director Division of Surgical / CDRH's office of Surveillance / Drug Administration / /
Person
David Brumfield / Silver Spring / Mo Alloy / Mark N. Melkerson / / /
Position
VP of Research and Development / Senior Vice President of Research and Development / Official Correspondent / /
KIII92~ FEB Section VII[removed]K) SUMMARY Date Prepared February 3, 2012