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Orthopedic surgery / Spinal fusion / Medical device / Degenerative disc disease / Lumbar vertebrae / Spondylolisthesis / Human vertebral column / Federal Food /  Drug /  and Cosmetic Act / Peek / Medicine / Vertebral column / Neurosurgery


K111792 Page 1 of[removed]k) Summary MAR[removed]January .2012
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Document Date: 2012-04-23 00:33:05


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File Size: 175,94 KB

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Company

BackcRoads Consulting Incorporated / K1 11792T1S Trade / AID 20993 Signus Medizintechnick GmbH / SIGNUS Medizintechnik GmbH / /

Currency

pence / /

Event

FDA Phase / /

/

IndustryTerm

treatment of degenerative disc disease / vertebral body replacement device / announcements concerning your device / predicate devices / body fusion device / worst case device / Internet address http /

MedicalCondition

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

MedicalTreatment

spinal surgery / /

Organization

Orthopedic And Restorative Devices Office / Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Mark N. Melkerson Director Division of Surgical / CDRH's office of Surveillance / /

Person

Mark N. Melkerson / Joachim Schneider / /

/

Position

Karen Warden / Ph- / surgeon / Warden / Karen Warden / /

Product

Federal Food / /

ProvinceOrState

Ohio / /

Technology

radiation / fundamental scientific technology / /

URL

http /

SocialTag