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Company Blackstone Medical / Biomet / Biologics / Aesculap Implant Systems / Paradigm Spine / Alphatec Spine / LDR Spine USA / DePuy Spine / Spondylolisthesis Developmental / Lifespine / Pedicle Screw Spinal Systems / Innovasis / Medtronic Spinal / Synthes / Globus Medical / Dynamic Stabilization Systems / Pioneer Surgical / EBI / Advisory Committee Classification Discussion Pedicle Screw Spinal Systems / Orthofix / LANX / / Continent Europe / / Country United States / / IndustryTerm treatment of degenerative disc disease / stabilization systems / 316L stainless steel / screw spine systems / Posterior spinal systems / component devices / Classification systems / screw fixation systems / screw spinal systems / secure fixation site / premarket applications / 316LVM stainless steel / 22Cr-13Ni-5Mn stainless steel / not support classifying pedicle screw spinal systems / / MedicalCondition deformities / Degenerative Disc Disease / pediatric deformities / Sterility / spinal tumor / postsurgical spondylolisthesis / deformity / Spondylolisthesis / disorder / spinal deformities / III Spondylolisthesis / degenerative spondylolisthesis / pediatric deformity / back pain / lumbar degenerative disorders / scoliosis / acute and chronic instabilities / tumor / normal lumbar lordosis / severe spondylolisthesis / spinal deformity / Disc Disease / dysplastic spondylolisthesis / kyphosis / either severe spondylolisthesis / spinal tumors / Types Spondylolisthesis / / MedicalTreatment surgery / surgical treatment / / Organization Food and Drug Administration / office of Surveillance and Biometrics Systematic Literature Search for DDD / Orthopaedic and Rehabilitation Devices Advisory Panel / Orthopedic Surgical Manufactures Association / FDA / / Position investigator / General / Executive / surgeon / / SocialTag 
DRAFT FDA Executive Summary