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City Rockville / / Company Ethicon Inc. / Agency for DSSs / General Medical Co. / FD&C Act / Thoracolumbosacral Rigid Pedicle Screw Systems / / Country United States / / / Event FDA Phase / / IndustryTerm treatment of degenerative disc disease / product development protocol / considered rigid pedicle screw systems / preadmendment device / risk devices / metal toxicity / final rule classifying pedicle screw spinal systems / predicate device / information technologies / prescription devices / rigid pedicle screw systems / preamendments device / pedicle screw spinal systems / postamendments devices / preamendment devices / dynamic stabilization systems / spinal systems / metal allergy / lordosis using rigid pedicle screw systems / pedicle screw systems / component devices / to any device / preamendments devices / / MedicalCondition deformities / spinal stenosis / allergic reaction / degenerative disc disease / metal allergy / sterility / neurological deficit/ injury / Tissue injury / spinal tumor / spinal curvatures / leg pain / injury / spondylolisthesis / degenerative spondylolisthesis / illness / scoliosis / acute and chronic instabilities / tumor / Severe spondylolisthesis / neurologic injury / neurological deficit/injury / seizure / pain / kyphosis / either severe spondylolisthesis / both spinal stenosis / infection / irritation / lordosis / / MedicalTreatment surgery / / Organization USDA / Dynamic Stabilization Systems AGENCY / office of Management and Budget / X. In addition / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / U.S.C. Chapter / Center for Devices and Radiological Health / Division of Dockets Management / FDA / Department of Health / / Person Rex A. Barnes / Silver Spring / / / Position Secretary / Associate Administrator / Governor / Executive / surgeon / adequate surgeon / / Product III preamendments device / Dynamic Stabilization Systems / III / S1 / DSSs / / ProgrammingLanguage C / / ProvinceOrState Maryland / / Technology information technologies / product development protocol / http / / URL www.fda.gov/AdvisoryCommittees / http / SocialTag