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City Rockville / / / IndustryTerm treatment of degenerative disc disease / cervical systems / risk devices / disc replacement devices / nonfusion spinal devices / spinal systems / facet screw fixation systems / pedicle screw systems / non-cervical systems / non-fusion devices / predicate device / screw fixation systems / nonpedicle cervical systems / touch-tone telephone / appropriate predicate device / vertebral body replacement devices / rod-based spinal systems / noncervical pedicle screw systems / noncervical systems / premarket approval applications / marketed systems / / MedicalCondition deformities / spinal stenosis / tumor / spondylolistheses / Pedicle System KWP spondylolisthesis / degenerative disc disease / severe spondylolisthesis / STERILITY / cervical spondylolysis / kyphosis / spondylolisthesis / either severe spondylolisthesis / degenerative spondylolisthesis / cervical spondylolisthesis / neck pain / back pain / scoliosis / lordosis / / MedicalTreatment surgery / / Organization U.S. Department of Health and Human Services / Food and Drug Administration / Division of Dockets Management / Food and Drug Administration Center for Devices / Neurological Devices office of Device Evaluation Contains Nonbinding Recommendations Preface Public Comment Comments / FDA / Radiological Health Orthopedic Devices Branch Division of General / / Person Restorative / Theodore Stevens / / / ProvinceOrState Maryland / / URL http / SocialTag 
Guidance for Industry and FDA Staff - Spinal System for 510(k)s