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Orthopedic surgery / Spinal fusion / Medical device / Spondylolisthesis / Degenerative disc disease / Back pain / Radiodensity / Integra LifeSciences / Premarket approval / Medicine / Vertebral column / Neurosurgery


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Document Date: 2014-06-06 11:52:05

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File Size: 138,95 KB

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City

Vista / /

Company

K133418 Trade / SeaSpine Inc. / Integra LifeSciences Corporation / /

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IndustryTerm

subject device / set practice manufacturing / body fusion device / ofimedical reporting device / predicate systems / lumbar interbody fusion devices / cited predicate devices / market thle device / manufacturing / yotur device / marketed predicate devices / Internet address fttp /

MedicalCondition

IBD / degenerative disc disease / disease / sterility / spondylolisthesis / back pain / /

MedicalTreatment

radiation / spinal surgery / /

OperatingSystem

Microsoft Vista / /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Division of Industry and Consumer Education / office of Device Evaluation / FDA / Division of Orthoedic-Devices Page / Device Evaluation Center for Devices and Radiological Health Enclosure lntegraO Expandable 18D System / Department of Defense / Sfor Mark N. Melkerson Director Division / CDRH's office of Surveillance / /

Person

Jeff Brittan / Ronald P.Jean -Sfor / Mark N. Melkerson / Jeffrey Brittan / /

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Position

Pa rt / Director / Engineering jeff.brittan@integralife.com Date Prepared / /

ProgrammingLanguage

C / /

ProvinceOrState

California / /

Technology

radiation / /

URL

http /

SocialTag