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Geriatrics / Vertebral column / Lumbar spinal stenosis / Spinal stenosis / Spondylolisthesis / Claudication / Spinal decompression / Neurogenic claudication / Human vertebral column / Medicine / Anatomy / Health


FDA Executive Summary VertiFlex® Superion® InterSpinous Spacer Prepared for the February 20, 2015, Meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
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City

Clemente / /

Company

Vanadium / /

Country

United States / /

Currency

pence / /

Event

Product Issues / /

IndustryTerm

subject device / titanium device / surgical site / investigational / control device / commercially-available devices / non-fusion interspinous process devices / control devices / /

MedicalCondition

Spinal Stenosis / radiculopathy / equina syndrome / specifically neurogenic intermittent claudication / peripheral vascular disease / significant peripheral neuropathy / disease / isthmic spondylolisthesis / osteophyte / severe osteoporosis / Leg Pain / allergy / symptomatic lumbar spinal stenosis / systemic disease / pain / numbness / neural compression causing neurogenic bladder / serious injury / significant scoliosis / Paget’s disease / spondylolisthesis / neurogenic intermittent claudication / lumbar spinal stenosis / advanced diabetes / angina / infection / active rheumatoid arthritis / degenerative spondylolisthesis / axial back pain / metastases / back pain / bowel dysfunction / moderate lumbar spinal stenosis / active systemic infection / morbid obesity / /

MedicalTreatment

spine surgery / cannula / /

Organization

Food and Drug Administration / Medical Devices Advisory Committee / Center for Devices and Radiological Health / FDA / /

Person

Compatibility Testing / /

Position

Executive / surgeon / /

Product

physical function / /

ProgrammingLanguage

HOC / /

ProvinceOrState

South Dakota / California / /

Technology

laser / X-ray / MRI / /

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