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City Coventry / Minneapolis / / Company Literature Review / Austenal Company / Spine-Tech Inc. / Medtronic / Spine Spinal Stabilizing Sphere System Interbody Innovations LLP / McCall / MEDLINE / Ames / / Country United States / / Event FDA Phase / / IndustryTerm treatment of degenerative disc disease / internal fixation device / similar device / search terms / post-amendments devices / intervertebral body fusion devices / interbody fusion devices / arthroplasty devices / cleared spinal sphere devices / stainless steel balls / spinal sphere device / treatment of degenerative disease / stainless steel ball bearings / arthroplasty device / control / premarket approval applications / interbody devices / pre-amendments device / intervertebral body fusion device / pedicle screw systems / non-fusion devices / sphere devices / cobalt-chrome spinal sphere device / spinal sphere devices / literature search / pre-amendments devices / preamendments devices / efficacious spinal fixation devices / / MedicalCondition temporary paresis / degenerative disc disease / headaches / sciatica / discogenic backache / spondylolisthesis / severe neck pain / lumbar lordosis / associated sciatica / pain / associated facet arthritis / degenerative disease / low back pain / discitis / herniated disc / / MedicalTreatment surgery / / OperatingSystem L3 / / Organization Food and Drug Administration / Orthopaedic and Rehabilitation Devices Advisory Panel / FDA / / Person Ulf Fernström / Paul Harmon / Cloward / / Position General / author / Representative / / Product Administration / Food / /
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FDA Executive Summary Prepared for the December 12, 2013 Meeting of the Orthopaedic and Rehabilitation Devices Panel Classification of Spinal Sphere Devices