New Hampshire Avenue Document Control Center / / /
IndustryTerm
supplemental internal spinal fixation systems / i.e. facet screw fixation systems / announcements concerning your device / predicate devices / body fusion device / lumbar intervertebral body fusion device / stand-alone device / rod systems / manufacturing practice requirements / marketed predicate devices / manufacturing practice / facet compression devices / Internet address http /
Organization
Orthopedic Devices Office / Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Device Evaluation Center for Devices / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / Mark N. Melkerson Director Division / CDRH’s office of Surveillance / /
Person
Lori A. Wiggins / Silver Spring / Mark N. Melkerson / Jane Metcalf / Sterile / / /
Position
Model / Vice President Quality Assurance / /
Product
Federal Food / Opticage™ Expandable Interbody Fusion / /
DEPARTMENT OF HEALTH & HUMAN SERVICES November 24, 2014 Public Health Service