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Orthopedic surgery / Neurosurgery / Implants / Prosthetics / Vertebral fixation / Scoliosis / Human vertebral column / Spondylolisthesis / Medical device / Medicine / Health / Vertebral column


K140765 -pagel1 of 2 JL121 510(k) Summary
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Document Date: 2014-08-08 12:37:26

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City

Leesburg / Spring / /

Company

Medtronic / Contact Person Nancy Giezen K2M Inc. / K2M Inc. / K 140765 Trade / /

Event

FDA Phase / /

IndustryTerm

Internet address http /

MedicalCondition

spinal stenosis / tumor / degenerative disc disease / adolescent idiopathic scoliosis / kyphosis / spondylolisthesis / i.e. scoliosis / back pain / lordosis / /

Organization

CDRl's office of Surveillance / Center for Devices and Radiological Health / ZanQAVkLt Division / Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / Radiological Health / Orthopedic Devices Office offDevice Evaluation Center for Devices / FDA / forMark N. Melkerson Director Division / Division of Postniarket Surveillance / European Union / An / Department of Health and Human Services / Division of Industry and Consumner Education / Division of Industry / /

Person

Denali Spinal / Nancy Giezen / /

/

Position

Manager / Regulatory Affairs / general information Onl / /

Product

Federal Food / /

ProvinceOrState

Virginia / /

Technology

radiation / http / /

URL

http /

SocialTag