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Vertebral column / Implants / Prosthetics / Vertebral fixation / Spinal fusion / Spondylolisthesis / Scoliosis / Kyphosis / Degenerative disc disease / Medicine / Orthopedic surgery / Neurosurgery


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Document Date: 2014-06-06 11:54:25

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City

Salt Lake City / /

Company

Innovasis Inc. / K140238 Trade / /

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Event

FDA Phase / /

Facility

New Hampshire Averue Document Control Center / /

IndustryTerm

treatment of degenerative disc disease / use devices / announcements concerning your device / ortto devices / predicate device / manufacturing practice requirements / Internet address http /

MedicalCondition

spinal stenosis / deformities / tumor / Degenerative disc disease / severe spondylolisthesis / degenemative spondylolisthesis / spinal tumor / kyphosis / deformity / spondylolisthesis / discogenic back pain / spinal deformities / degenerative spondylolisthesis / Scheuermann's disease / scoliosis / lordosis / acute and chronic instabilities / /

MedicalTreatment

orthopedic surgery / surgery / spinal surgery / /

Organization

Orthopedic Devices Office / Division of Industry and Consumer Education / Food and Drug Administration / New Hampshire Averue Document Control Center / Center for Devices and Radiological Health / Division of Posirnarket Surveillance / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / Department of Defense / An / DEPARTMENT OF HEALTH / Sfor Mark N. Melkerson Director Division / Device Evaluation Center for Devices and Radiological Health Enclosure / CDRH's office of Surveillance / /

Person

Marshall C. McCarty / James P.Berrr / Mark N. Melkerson / /

/

Position

screw head / reduction head / physician / extended length head / Director / QAIRA / head / Marshall / /

Product

Cobalt / Spinal / Federal Food / Spinal System / /

ProvinceOrState

Utah / Maryland / /

Region

South Salt / /

Technology

radiation / /

URL

http /

SocialTag