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Orthopedic surgery / Spondylolisthesis / Vertebral fixation / Scoliosis / Degenerative disc disease / Back pain / DePuy / Kyphosis / Spinal stenosis / Medicine / Vertebral column / Neurosurgery


g2,[removed]MAY 510(K) SUMMARY A.
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Document Date: 2012-06-11 00:35:59

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File Size: 154,62 KB

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City

Paramount Drive Raynham / /

Company

DePuy Spine Incorporated / Johnson & Johnson / Class Class Ill D. Device Name Trade / VIPER Systems / K121020 Trade / F. Predicate Device Name Trade / VIPERS Systems / A. Submitter Information DePuy Spine Inc / /

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Event

FDA Phase / /

IndustryTerm

announcements concerning your device / predicate device / manufacturing practice requirements / predicate systems / grade stainless steel / Internet address http /

MedicalCondition

deformities / spinal stenosis / tumor / degenerative disc disease / kyphosis / spondylolisthesis / discogenic spondylolisthesis / back pain / scoliosis / acute and chronic instabilities / /

Organization

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

Person

Silver Spring / Kirsten Lehmuller / Mark N. Melkerson / /

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Product

Federal Food / /

ProgrammingLanguage

K / /

ProvinceOrState

Maryland / Massachusetts / /

Technology

radiation / http / /

URL

http /

SocialTag