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Neurosurgery / Orthopedic surgery / Food and Drug Administration / Implants / Vertebral fixation / Spondylolisthesis / Scoliosis / Human vertebral column / Federal Food / Drug / and Cosmetic Act / Medicine / Health / Vertebral column


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Document Date: 2014-07-18 16:18:33

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File Size: 148,48 KB

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City

Fl Leesburg / Suite FlI Leesburg / Leesburg / /

Company

K141147 Trade / Medtronic / K2M Inc. / VA 20175 Contact Person Nancy Giezen K2M Inc. / /

Facility

New Hamrpshire Avenue Documnent Control Center / /

IndustryTerm

announcements concerning your device / predicate devices / manufacturing practice requirements / marketed predicate devices / Internet address http /

MedicalCondition

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

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Center for Devices and Radiological Health / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / DEPARTMENT OF HEALTH / Sfor Mark N. Melkerson Director Division / Device Evaluation Center for Devices and Radiological Health Enclosure / New Hamrpshire Avenue Documnent Control Center / /

Person

Silver Spring / Ronald P.Jean -Sfor / Nancy Giezen / Mark N. Melkerson / /

/

Position

Manager / Regulatory Affairs / /

ProvinceOrState

Virginia / Maryland / /

Technology

radiation / /

URL

www.fda~gov/MedicalDevices/ResourcesforYou/Indust/defaul.htm / http /

SocialTag