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Vertebral column / Orthopedic surgery / Food law / Spinal fusion / Medical device / Degenerative disc disease / Spondylolisthesis / Federal Food /  Drug /  and Cosmetic Act / Premarket approval / Medicine / Neurosurgery / Food and Drug Administration


JUL[removed]k Summary Spacer System PLATEAU
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Document Date: 2011-08-25 18:40:31


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File Size: 138,68 KB

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City

Hoffman Estates / /

Company

Medtronic / 2M Life Spine Inc. / KI 11569 Trade / Orthofix / Invibio / Life Spine Inc. / /

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IndustryTerm

announcements concerning your device / predicate devices / intervertebral body fusion device / body fusion device / manufacturing practice requirements / predicate systems / Internet address littp /

MedicalCondition

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

Organization

Orthopedic And Restorative Devices Office / S-Mark N. Melkerson Director Division of Surgical / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Surveillance / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Postmnarket Surveillance / Center for Devices / /

Person

OPTIMA LT / Randy Lewis / /

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ProvinceOrState

Illinois / /

Technology

radiation / http / /

SocialTag