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Spondylolisthesis / Degenerative disc disease / Medical device / Scoliosis / Biomet / Human vertebral column / Back pain / Vertebral fixation / Spinal fusion / Medicine / Vertebral column / Anatomy


eii2 510(k) Summary PILOT Spinal System SEP-721
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Document Date: 2011-10-31 00:33:13

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File Size: 140,90 KB

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City

Hoffman Estates / /

Company

Z.01 Life Spine Inc. / qualIity Systems / K1 11729 Trade / Life Spine Inc. / /

Currency

pence / /

Event

FDA Phase / /

/

IndustryTerm

announcemnents concerin your device / Internet address hittp /

MedicalCondition

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

Organization

N. NMelkerson Director Division of'Surgical / Orthopedic and Restorative Devices office / office of Compliance / Division of Smnall ManuIfactUrers / International and Consume~nr Assistance / FDA / DEPARTMENT OF HEALTH / Mark N. NMelkerson Director Division / Center for Devices / /

Person

Randy L.ewis / Technological Characteristics / Randy Lewis / /

/

Position

PILOT / /

Product

Federal Food / /

ProgrammingLanguage

PILOT / /

ProvinceOrState

Illinois / /

TVStation

KIII / /

Technology

radiation / /

SocialTag