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Neurosurgery / Implants / Prosthetics / Vertebral fixation / Spondylolisthesis / Scoliosis / Degenerative disc disease / Human vertebral column / Spinal stenosis / Medicine / Vertebral column / Orthopedic surgery


Ki132575 Page 1 of[removed]k) SUMMARY 1. GENERAL INFORMATION Date Prepared
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Document Date: 2013-11-14 08:33:36

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City

Lyon / /

Company

LP Spinal Systems / OLr030 Contact 01700 NEYRON Trade Names PASS LP / The PASS LP / K132575 Trade / /

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Event

FDA Phase / /

IndustryTerm

announcements concerning your device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / /

MedicalCondition

Spinal stenosis / deformities / tumor / degenerative disc disease / severe spondylolisthesis / tumors / Spinal stenosis *Degenerative spondylolisthesis / Adolescent Idiopathic Scoliosis / kyphosis / spondylolisthesis / Degenerative spondylolisthesis / back pain / scoliosis / lordosis / acute and chronic instabilities / /

Organization

Orthopedic Devices Office / Division of Small Manufacturers / Division of Postnarkct Surveillance / office of Device Evaluation / FDA / Device Evaluation Center for Devices / CDRI-l's office of Surveillance / Division of Orthopedic Devices / DEPARTMENT OF HEALTH / /

Person

Audrey Vion / Amy S.Graf / Mark N. Melkerson / /

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Position

GENERAL INFORMATION Date / Director Division ol / Regulatory Affairs Manager / /

Product

Spinal System / Kyocera K132 Cellular Phone / Federal Food / /

Technology

radiation / http / /

URL

http /

SocialTag