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Osteology / Neurosurgery / Degenerative disc disease / DePuy / Orthopedic surgery / Human vertebral column / Lumbar vertebrae / Back pain / Spinal fusion / Anatomy / Medicine / Vertebral column


Document Date: 2011-04-25 00:31:10

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City

Raynham / Paramount Drive Raynham / /

Company

DePuy Spine Inc. / Submitter Information DePuy Spine Inc. / Johnson & Johnson / Fusion Device (888.3080) Predicate Device Name Trade / Bengal Systems / K103488 Trade / C. Device Name D. Trade / /

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Event

FDA Phase / /

IndustryTerm

vertebral body replacement device / announcements concerning your device / intervertebral body fusion devices / predicate device / interbody fusion devices / manufacturing practice requirements / predicate systems / marketed predicate devices / Internet address http /

MedicalCondition

degenerative disc disease / tumors / discogenic back pain / /

MedicalTreatment

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 Evaluato DE / 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

Silver Spring / Kevin G.Stevens / Mark N. Melkerson / /

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Position

Regulatory Affairs Project Manager / /

Product

Federal Food / /

ProvinceOrState

Maryland / Massachusetts / /

Technology

radiation / x-ray / /

URL

http /

SocialTag