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Vertebral column / Degenerative disc disease / Spondylolisthesis / Medical device / Human vertebral column / Lumbar vertebrae / Back pain / Federal Food / Drug / and Cosmetic Act / Spine / Medicine / Anatomy / Health


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Document Date: 2014-03-07 12:04:55

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City

Chesterland / Powell / /

Company

DeRoyal Industries Inc. / K131292 Trade / Warden Ph.D. Representative/Consultant BackRoads Consulting Incorporated / /

Country

United States / /

Currency

pence / /

Event

FDA Phase / /

Facility

New Hamipshire Avenue Document Control Center / /

IndustryTerm

treatment of degenerative disc disease / The/device / vertebral body replacement device / announcements concerning your device / predicate devices / body fusion device / supplemental fixation systems / manufacturing practice requirements / marketed predicate devices / manufacturing practice / cleared devices / fundamental scientific technology / Internet address http /

MedicalCondition

tumor / degenerative disc disease / spondylolisthesis / back pain / /

MedicalTreatment

spinal surgery / /

Organization

Device Evaluation Center / Orthopedic Devices Office / New Hamipshire Avenue Document Control Center / Division of Postmarket Surveillance / office of Device Evaluation / FDA / Department of Defense / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Mark N. Melkerson Director Division / CDRH's office of Surveillance / /

Person

Silve Spring / Mark N. Melkerson / Nephi Zufelt / /

/

Position

Director of Engineering and Regulatory Affairs Trade Name / Warden / Karen Warden / /

Product

Federal Food / /

ProvinceOrState

Ohio / Tennessee / /

Technology

radiation / fundamental scientific technology / /

URL

www.deroyal.com / http /

SocialTag