Back to Results
First PageMeta Content
Premarket approval / Spondylolisthesis / Federal Food /  Drug /  and Cosmetic Act / Investigational Device Exemption / Spinal fusion / Center for Devices and Radiological Health / Medical device / Scoliosis / Spinal stenosis / Medicine / Health / Food and Drug Administration


TKELLEY on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 79, No[removed]Wednesday, November 12, [removed]Proposed Rules providing an incentive for entities to remit their assessments in a timely manner, with the in
Add to Reading List

Document Date: 2014-11-11 18:09:20


Open Document

File Size: 298,78 KB

Share Result on Facebook

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